Microbiologics recalls QC Sets and KWIK-STIK AST-GP kits with catalog numbers 5220P and 0959P that may return incorrect bacterial susceptibility results, risking inaccurate infection treatment decisions.
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 (6 Strains) kits that may give incorrect bacterial susceptibility test results. This could lead to improper antibiotic treatment decisions if used in clinical settings.
These QC kits may produce incorrect results when testing bacterial susceptibility to antibiotics. Specifically, the high-level gentamicin synergy values were out of specification on the Vitek 2 AST-GP67 card, and the disk diffusion method failed during product release testing.
Healthcare professionals using these kits for bacterial susceptibility testing in clinical labs. The risk is low as the kits are used for quality control in diagnostic settings.
Check for the catalog number 5220P on the QC Sets and Panels, or catalog number 0959P on the KWIK-STIK AST-GP kit. Lot numbers 5220-01 through 5220-06 with expiration dates from 04/30/2020 to 01/31/2021 are affected.
Verify the catalog number and lot numbers on the kit to confirm if it is affected.
The kits may return incorrect bacterial susceptibility results, which could lead to improper antibiotic treatment decisions if used in clinical settings.
QC Sets and Panels with catalog number 5220P, and KWIK-STIK AST-GP (6 Strains) kits with catalog number 0959P.
Check for lot numbers 5220-01 through 5220-06 with expiration dates from 04/30/2020 to 01/31/2021.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0588-2022 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-0588-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
