Skip to content

KWIK-STIKRecalls & reported problems across all models

Microbiologics Inc. · 20 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

8 open recalls name at least one KWIK-STIK model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
23

We found 20 models of KWIK-STIK by Microbiologics Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

23 FDA recall records name at least one of these models by its device identifier, 8 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

KWIK-STIK recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Dec 2, 2025Open, Classified

    Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

    Z-0985-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Dec 2, 2025Open, Classified

    Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

    Z-0984-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Nov 13, 2025Open, Classified

    Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

    Z-0876-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  4. Jun 27, 2025Open, Classified

    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.

    Z-2194-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  5. Jun 17, 2025Open, Classified

    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.

    Z-2124-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  6. May 27, 2025Open, Classified

    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.

    Z-1957-2025 · Root cause: Mixed-up of materials/components · names 2 of these models · Recall details · FDA record ↗

  7. Mar 6, 2024Open, Classified

    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 material.

    Z-1483-2024 · Root cause: Use error · Recall details · FDA record ↗

  8. Oct 18, 2023Open, Classified

    A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

    Z-0307-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  9. May 6, 2022Terminated

    Labeling error.

    Z-1125-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

  10. Feb 24, 2021Terminated

    Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.

    Z-0544-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

  11. Feb 24, 2021Terminated

    Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

    Z-0543-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

  12. Dec 16, 2020Terminated

    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.

    Z-0546-2022 · Root cause: Employee error · Recall details · FDA record ↗

  13. Dec 16, 2020Terminated

    Contamination with S. epidermidis

    Z-0511-2022 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

  14. Oct 8, 2020Terminated

    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 and KWIK-STIK" device label.

    Z-0581-2022 · Root cause: Employee error · Recall details · FDA record ↗

  15. Oct 8, 2020Terminated

    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.

    Z-0303-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  16. Oct 8, 2020Terminated

    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.

    Z-0302-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  17. Oct 8, 2020Terminated

    Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

    Z-0402-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  18. Oct 1, 2020Terminated

    Potential contamination with S. epidermidis E. coli and S. warneri.

    Z-0582-2022 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

  19. Feb 18, 2020Terminated

    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.

    Z-0585-2022 · Root cause: Process design · Recall details · FDA record ↗

  20. Feb 12, 2020Terminated

    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.

    Z-1690-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  21. Mar 2, 2017Terminated

    Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

    Z-0636-2022 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗

  22. Oct 6, 2014Terminated

    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.

    Z-0712-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  23. Mar 25, 2013Terminated

    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 error and the organism is the correct organism.

    Z-0641-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

KWIK-STIK models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Microbiologics Inc. products

All Microbiologics Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page