Biomerieux recalls RAPID 20 E system (lot 1008332150, exp 2022-04-20; lot 1008787180, exp 2022-12-12) due to incorrect color for negative CIT test results in package insert.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
Biomerieux is recalling its RAPID 20 E system because the package insert shows the wrong color for a negative result in the CIT test. This could lead to misinterpreting test results, but it does not pose a physical safety risk.
The package insert incorrectly lists the color for a negative result in the CIT test. This could cause lab personnel to misinterpret test results, potentially leading to incorrect diagnoses or treatment decisions.
Users of the RAPID 20 E system for identifying Enterobacteriaceae bacteria in clinical labs. Lab technicians handling the system are most at risk of misinterpreting test results.
Check for lot numbers 1008332150 (expires April 20, 2022) or 1008787180 (expires December 12, 2022) on the RAPID 20 E system packaging.
Verify the color code for negative results in the package insert matches the correct color as specified by Biomerieux.
No, this recall is for a potential misinterpretation of test results due to an incorrect color code in the package insert. It does not pose a physical safety risk.
Check the lot number on your packaging. If it matches 1008332150 (expires April 20, 2022) or 1008787180 (expires December 12, 2022), review the package insert for the correct color code for negative results.
Look for lot numbers 1008332150 (expires April 20, 2022) or 1008787180 (expires December 12, 2022) on the RAPID 20 E system packaging.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0422-2022 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0422-2022 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.
