# K080107: Vitek 2 Gram Negative Piperacillin/Tazobactam

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 28, 2008 after 44 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 114 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032788 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072038: Vitek 2 Gram Negative Levofloxacin, bioMerieux, Inc. (2007) Summary page 1.

## Recalls of this device
- Apr 4, 2011 · Not classified · Z-2049-2011: 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 dr
- Apr 4, 2011 · Not classified · Z-2050-2011: 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 dr
- Sep 16, 2010 · Not classified · Z-0222-2011: 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
- Sep 16, 2010 · Not classified · Z-0201-2011: 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
- Sep 16, 2010 · Not classified · Z-0239-2011: 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
- Sep 16, 2010 · Not classified · Z-0195-2011: 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
- Sep 16, 2010 · Not classified · Z-0197-2011: 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
- Sep 16, 2010 · Not classified · Z-0207-2011: 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
- Sep 16, 2010 · Not classified · Z-0176-2011: 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
- Sep 16, 2010 · Not classified · Z-0210-2011: 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
- Sep 16, 2010 · Not classified · Z-0181-2011: 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
- Sep 16, 2010 · Not classified · Z-0180-2011: 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
- Sep 16, 2010 · Not classified · Z-0193-2011: 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
- Sep 16, 2010 · Not classified · Z-0191-2011: 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
- Sep 16, 2010 · Not classified · Z-0215-2011: 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
- Sep 16, 2010 · Not classified · Z-0187-2011: 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
- Sep 16, 2010 · Not classified · Z-0206-2011: 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
- Sep 16, 2010 · Not classified · Z-0199-2011: 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
- Sep 16, 2010 · Not classified · Z-0233-2011: 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
- Sep 16, 2010 · Not classified · Z-0192-2011: 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
- Sep 16, 2010 · Not classified · Z-0246-2011: 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
- Sep 16, 2010 · Not classified · Z-0204-2011: 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
- Sep 16, 2010 · Not classified · Z-0178-2011: 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
- Sep 16, 2010 · Not classified · Z-0175-2011: 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
- Sep 16, 2010 · Not classified · Z-0184-2011: 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
- Sep 16, 2010 · Not classified · Z-0182-2011: 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
- Sep 16, 2010 · Not classified · Z-0209-2011: 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
- Sep 16, 2010 · Not classified · Z-0212-2011: 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
- Sep 16, 2010 · Not classified · Z-0189-2011: 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
- Sep 16, 2010 · Not classified · Z-0194-2011: 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
- Sep 16, 2010 · Not classified · Z-0186-2011: 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
- Sep 16, 2010 · Not classified · Z-0213-2011: 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
- Sep 16, 2010 · Not classified · Z-0196-2011: 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
- Sep 16, 2010 · Not classified · Z-0202-2011: 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
- Sep 16, 2010 · Not classified · Z-0185-2011: 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
- Sep 16, 2010 · Not classified · Z-0205-2011: 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
- Sep 16, 2010 · Not classified · Z-0198-2011: 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
- Sep 16, 2010 · Not classified · Z-0228-2011: 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
- Sep 16, 2010 · Not classified · Z-0188-2011: 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
- Sep 16, 2010 · Not classified · Z-0230-2011: 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
- Sep 16, 2010 · Not classified · Z-0200-2011: 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
- Sep 16, 2010 · Not classified · Z-0236-2011: 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
- Sep 16, 2010 · Not classified · Z-0172-2011: 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
- Sep 16, 2010 · Not classified · Z-0208-2011: 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
- Sep 16, 2010 · Not classified · Z-0203-2011: 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
- Sep 16, 2010 · Not classified · Z-0190-2011: 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
- Sep 16, 2010 · Not classified · Z-0177-2011: 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
- Sep 16, 2010 · Not classified · Z-0173-2011: 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
- Sep 16, 2010 · Not classified · Z-0174-2011: 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
- Sep 16, 2010 · Not classified · Z-0179-2011: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K080107
Methodology: https://510kreport.com/methodology