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QC Sets and Panels: KWIK-STIK 2 PackRecalls & reported problems across all models

Microbiologics Inc. · 6 models in the FDA device registry

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

1 open recall names at least one QC Sets and Panels: KWIK-STIK 2 Pack 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
7

We found 6 models of QC Sets and Panels: KWIK-STIK 2 Pack by Microbiologics Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

7 FDA recall records name at least one of these models by its device identifier, 1 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

QC Sets and Panels: KWIK-STIK 2 Pack 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. Aug 14, 2023Open, Classified

    One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

    Z-2576-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

  2. Oct 8, 2020Terminated

    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.

    Z-0304-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Oct 1, 2020Terminated

    Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.

    Z-0584-2022 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

  4. 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-0589-2022 · Root cause: Process design · Recall details · FDA record ↗

  5. 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-0588-2022 · Root cause: Process design · Recall details · FDA record ↗

  6. 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-0587-2022 · Root cause: Process design · Recall details · FDA record ↗

  7. 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-1691-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

QC Sets and Panels: KWIK-STIK 2 Pack models

6 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

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