bioMerieux recalls VITEK 2 antimicrobial testing products that may show false resistance to Streptococcus anginosus and constellatus strains. Affected items include specific catalog numbers for laboratory use.
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
bioMerieux is recalling certain VITEK 2 antimicrobial susceptibility testing products that could give false resistant results for specific streptococcal strains. This could lead to incorrect antibiotic treatment decisions in clinical settings.
The products may produce false results indicating resistance to antibiotics for certain streptococcal strains. This could lead to incorrect antibiotic treatment choices if the false results are not recognized.
Laboratory professionals using the VITEK 2 systems with the listed catalog numbers are most at risk. The recall affects specific antimicrobial susceptibility testing products used in clinical labs.
Check for catalog numbers 410028, 420915, or 421040 on the VITEK 2 AST products. These items are used in clinical laboratories for antimicrobial susceptibility testing.
Verify if your VITEK 2 products have catalog numbers 410028, 420915, or 421040.
The affected products are VITEK 2 AST-ST01 (catalog #410028), AST-ST02 (catalog #420915), and AST-ST03 (catalog #421040).
The products may produce false resistant results for Streptococcus anginosus and Streptococcus constellatus strains, which could lead to incorrect antibiotic treatment decisions.
No action is required beyond checking the catalog numbers. The recall does not require immediate discontinuation.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0618-2019 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0618-2019 from bioMerieux. 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.