Microbiologics recalls LYFO-DISK Enterococcus faecalis test kits that may give incorrect susceptible results, risking inaccurate infection treatment decisions. Affected lots from 2020-2021.
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 LYFO-DISK Enterococcus faecalis test kits that may give incorrect results, which could lead to improper antibiotic treatment decisions. This recall affects specific lots manufactured between April 2020 and March 2021.
These test kits may produce incorrect susceptible results when used with certain antibiotics. This could lead to improper antibiotic treatment decisions if the test results are relied upon.
Laboratory users and healthcare professionals who may have used these test kits. Those using the kits for infection testing are most at risk of incorrect results.
Check for specific catalog numbers: 0959L. Look for lot numbers 959-94-1 through 959-97-3 with expiration dates from April 2020 to March 2021.
Verify the catalog number and lot numbers listed in the recall notice to confirm if your kit is affected.
The test kits may produce incorrect susceptible results when used with certain antibiotics, potentially leading to improper antibiotic treatment decisions.
The recall notice does not specify a remedy, so check the product details to confirm if it is affected and contact Microbiologics for further guidance.
Lots with catalog number 0959L and lot numbers 959-94-1 through 959-97-3, expiring from April 2020 to March 2021.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-0586-2022 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-0586-2022 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.
