Microbiologics recalls QC sets and KWIK-STIK AST-GP kits that may return incorrect bacterial susceptibility results, affecting lab testing accuracy.
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.
Microbiologics is recalling QC sets and KWIK-STIK AST-GP kits that may give incorrect test results for bacterial susceptibility. This could lead to inaccurate lab results and improper treatment decisions.
The kits may return incorrect bacterial susceptibility results due to high Gentamicin Synergy values outside normal specifications. This can happen when tested on Vitek 2 AST-GP67 cards or during disk diffusion methods.
Laboratory users who test bacteria with these kits may be affected. The risk is low as the issue only impacts test accuracy, not immediate safety.
Check for the KWIK-STIK AST-GP (4 Strains) QC Set with Catalog Number 0959P. Lot numbers 5112-01 (expiring 07/31/2020) or 5112-02 (expiring 10/31/2020) are affected.
Verify the catalog number (0959P) and lot numbers (5112-01 or 5112-02) to confirm if your kit is affected.
No, the recall only affects test accuracy, not immediate safety. Continue using but check for affected kits.
Check the catalog number and lot numbers to confirm if your kit is affected. If so, contact Microbiologics for guidance.
Affected kits have Catalog Number 0959P and Lot Numbers 5112-01 (expiring 07/31/2020) or 5112-02 (expiring 10/31/2020).
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0587-2022 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-0587-2022 from Microbiologics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
