Biomerieux recalls ETEST IMIPENEM RELEBACTAM in vitro diagnostics due to false resistant results for Pseudomonas aeruginosa. Affected lots include 1007888860, 1008598340, and others. Stop using if you have these lots.
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Biomerieux is recalling ETEST IMIPENEM RELEBACTAM diagnostic tests because they sometimes show false 'resistant' results for Pseudomonas aeruginosa bacteria. This could lead to incorrect antibiotic treatment decisions. The recall affects specific lot numbers sold in the US.
The tests can incorrectly indicate that Pseudomonas aeruginosa bacteria are resistant to antibiotics when they are actually susceptible. This could lead to inappropriate antibiotic choices. The risk is limited to specific lab testing scenarios.
Healthcare professionals using these tests for bacterial susceptibility testing are most at risk. Patients may be affected if incorrect antibiotic treatment decisions result from false results.
Check the lot number on the ETEST IMIPENEM RELEBACTAM packaging. Affected lots include 1007888860, 1008598340, 1008701580, and others listed in the recall notice.
Look for the lot number on the ETEST IMIPENEM RELEBACTAM packaging to see if it matches the affected lots listed in the recall.
No, but you should check the lot number to see if it's affected. If it is, you should stop using it.
Contact Biomerieux directly to confirm if your lot is affected and follow their instructions.
The recall is for lab testing; patients are not directly at risk unless incorrect antibiotic treatment decisions are made based on false results.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2226-2021 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-2226-2021 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.
