Microbiologics recalls QC sets and KWIK-STIK blood culture panels that may return incorrect susceptible results, affecting infection 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 blood culture verification panels that may give incorrect test results. This could lead to inaccurate infection treatment decisions if used in medical settings.
These test kits may produce incorrect susceptible results when used with certain blood culture systems. This could lead to improper antibiotic treatment decisions if the tests are relied upon for infection management.
Healthcare facilities using these QC sets and panels for blood culture testing may be affected. Patients receiving treatment based on these tests could be at risk if results are incorrect.
Check for the catalog number 0959P on the KWIK-STIK kit. Lot numbers 5229-01 (exp 07/31/2020), 5229-02 (exp 09/30/2020), and 5229-03 (exp 09/30/2020) are affected.
Look for catalog number 0959P on the KWIK-STIK kit and check the lot numbers listed above.
These kits may return incorrect susceptible results when used with certain blood culture systems, potentially leading to inaccurate infection treatment decisions.
Lot numbers 5229-01 (exp 07/31/2020), 5229-02 (exp 09/30/2020), and 5229-03 (exp 09/30/2020) are affected.
The recall does not specify a stop-use instruction, but affected kits should be checked and replaced if they match the listed details.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0589-2022 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-0589-2022 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.
