510(k) · Cleared
Recalled · Class II · 2025Kwik Stik (TM) Lyfo (TM) Disk Microorganisms
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Bio-Logics · JTR Kit, Quality Control For Culture Media
Cleared on Apr 4, 1986 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 40 times.
- Decided
- Apr 4, 1986
- Review
- 17 days
- Class
- Class I
- Product code
- JTR
- Recalls
- 40
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JTR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Dec 2, 2025 | Class II | Z-0984-2026 | Under Investigation by firm | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| Dec 2, 2025 | Class II | Z-0985-2026 | Under Investigation by firm | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| Dec 2, 2025 | Class II | Z-0986-2026 | Under Investigation by firm | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| Jun 27, 2025 | Class II | Z-2194-2025 | Under Investigation by firm | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. |
| Jun 17, 2025 | Class II | Z-2124-2025 | Under Investigation by firm | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient. |
| May 27, 2025 | Class II | Z-1957-2025 | Mixed-up of materials/components | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis. |
| Mar 6, 2024 | Class II | Z-1483-2024 | Use error | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control… |
| Oct 18, 2023 | Class II | Z-0307-2024 | Under Investigation by firm | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. |
| Oct 18, 2023 | Class II | Z-0308-2024 | Under Investigation by firm | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. |
| Aug 14, 2023 | Class III | Z-2576-2023 | Packaging process control | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. |
| May 6, 2022 | Class III | Z-1125-2022 | Labeling mix-ups | Labeling error. |
| Feb 24, 2021 | Class III | Z-0543-2022 | Labeling mix-ups | Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. |
| Feb 24, 2021 | Class III | Z-0544-2022 | Labeling mix-ups | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. |
| Dec 16, 2020 | Class III | Z-0546-2022 | Employee error | The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022. |
| Dec 16, 2020 | Class II | Z-0511-2022 | Material/Component Contamination | Contamination with S. epidermidis |
| Oct 8, 2020 | Class II | Z-0302-2021 | Under Investigation by firm | KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. |
| Oct 8, 2020 | Class II | Z-0303-2021 | Under Investigation by firm | KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. |
| Oct 8, 2020 | Class II | Z-0304-2021 | Under Investigation by firm | QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. |
| Oct 8, 2020 | Class II | Z-0402-2021 | Under Investigation by firm | Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. |
| Oct 8, 2020 | Class III | Z-0581-2022 | Employee error | The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label… |
| Oct 1, 2020 | Class II | Z-0582-2022 | Unknown/Undetermined by firm | Potential contamination with S. epidermidis E. coli and S. warneri. |
| Oct 1, 2020 | Class II | Z-0583-2022 | Unknown/Undetermined by firm | Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. |
| Oct 1, 2020 | Class II | Z-0584-2022 | Unknown/Undetermined by firm | Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. |
| Feb 18, 2020 | Class II | Z-0587-2022 | Process design | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. |
| Feb 18, 2020 | Class II | Z-0589-2022 | Process design | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. |
| Feb 18, 2020 | Class II | Z-0586-2022 | Process design | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. |
| Feb 18, 2020 | Class II | Z-0588-2022 | Process design | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. |
| Feb 18, 2020 | Class II | Z-0585-2022 | Process design | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release. |
| Feb 12, 2020 | Class II | Z-1691-2020 | Nonconforming Material/Component | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis. |
| Feb 12, 2020 | Class II | Z-1690-2020 | Nonconforming Material/Component | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis. |
| Mar 2, 2017 | Class III | Z-0636-2022 | Labeling False and Misleading | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. |
| Mar 2, 2017 | Class III | Z-0637-2022 | Labeling False and Misleading | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. |
| Dec 1, 2015 | Class II | Z-0704-2022 | Material/Component Contamination | The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This… |
| Dec 1, 2015 | Class II | Z-0703-2022 | Material/Component Contamination | The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This… |
| Jul 17, 2015 | Class III | Z-0788-2022 | Labeling mix-ups | LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to… |
| Oct 6, 2014 | Class II | Z-0712-2022 | Nonconforming Material/Component | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. |
| Oct 6, 2014 | Class II | Z-0713-2022 | Nonconforming Material/Component | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. |
| Oct 6, 2014 | Class II | Z-0714-2022 | Nonconforming Material/Component | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. |
| Mar 25, 2013 | Class III | Z-0641-2022 | Labeling mix-ups | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling… |
| Oct 12, 2007 | Not classified | Z-0456-2008 | Employee error | Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris. |
The 5 latest of 40 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JTR devicesJTR Kit, Quality Control For Culture Media: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JTR
FDA has decided no JTR device since 2007.
Median 510(k) review, days · JTR
Too few JTR 510(k)s in any year since 2007 to give a median.
Recalls per year · JTR
4in 2025
2007high 15 (2020) · low 0 (2008)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JTR
1in 2015
2007high 1 (2015) · low 0 (2007)2025
MAUDE reports naming product code JTR, 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 | 0 | — | 4 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 3 | 0 |
| 2015 | 0 | — | 3 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 15 | 0 |
| 2021 | 0 | — | 2 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 4 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K861022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861022: Kwik Stik (TM) Lyfo (TM) Disk Microorganisms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861022
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026