510(k) · Cleared
Recalled · 2011Vitek 2 Gram Negative Piperacillin/Tazobactam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Feb 28, 2008 as substantially equivalent to K072038 (bioMerieux, Inc., 2007) after a 44-day review. Its family tree reaches back 3 generations to 2003. It has been recalled 114 times.
- Decided
- Feb 28, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- LON
- Recalls
- 114
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032788 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- 2 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
- 1 generation backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- This deviceK080107 Vitek 2 Gram Negative Piperacillin/TazobactambioMerieux, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| −2 | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | 1 |
| −1 | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| 0 (this device) | K080107 | Vitek 2 Gram Negative Piperacillin/Tazobactam | bioMerieux, Inc. | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072038 | Vitek 2 Gram Negative LevofloxacinSummary page 1…866.1645 Common Name: VITEK 2 AST-GN Piperacillin/Tazobactam C. Predicate Device: VITEK 2 Gram Negative Levofloxacin (K072038). D. 510(k) Summary: VITEK® 2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing… | 2007 |
| † | K050002 | Vitek 2 Compact | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2011 | Not classified | Z-2049-2011 | Nonconforming Material/Component | The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant… |
| Apr 4, 2011 | Not classified | Z-2050-2011 | Nonconforming Material/Component | The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant… |
| Sep 16, 2010 | Not classified | Z-0222-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0201-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0239-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0195-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0197-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0207-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0176-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0210-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0181-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0180-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0193-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0191-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0215-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0187-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0206-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0199-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0233-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0192-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0246-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0204-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0178-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0175-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0184-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0182-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0209-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0212-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0189-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0194-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0186-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0213-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0196-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0202-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0185-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0205-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0198-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0228-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0188-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0230-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0200-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0236-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0172-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0208-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0203-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0190-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0177-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0173-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0174-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
| Sep 16, 2010 | Not classified | Z-0179-2011 | Nonconforming Material/Component | AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K072038.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2007high 19 (2007) · low 0 (2015)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
2007high 268 (2021) · low 50 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
2007high 116 (2010) · low 0 (2007)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
2007high 690 (2025) · low 0 (2009)2025
MAUDE reports naming product code LON, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
VITEK® 2 Gram Negative Piperacillin/tazobactam is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin/tazobactam is a quantitative test. Piperacillin/tazobactam has been shown to be active against most strains of the organisms listed…
Read the full statement (156 words)
VITEK® 2 Gram Negative Piperacillin/tazobactam is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin/tazobactam is a quantitative test. Piperacillin/tazobactam has been shown to be active against most strains of the organisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections
Acinetobacterbaumanii Klebsiella pneumoniae
Escherichia coli Pseudomonasaeruginosa
Active in vitro but their clinical significance isuknown:
Citrobacterkoseri Proteus vulgaris Salmonella enterica
Morganella morganil Providenciarettgeri Serratia marcescens
Proteus mirabilis Providenciastuartll
The VITEKe 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcusspp., Streptococcus agalactiae, and S. pneumoniae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080107: Vitek 2 Gram Negative Piperacillin/Tazobactam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080107
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026