Biomerieux recalls API JAMES 2AMP (catalog 705:42) due to temperature and time exposure affecting performance. Affected units include specific batch numbers and UDI/DI codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling its API JAMES 2AMP devices because they may not function properly if exposed to temperatures or times outside the specified range. This could lead to unreliable results in laboratory testing.
The product may not perform as intended if it is exposed to temperatures or time periods outside the manufacturer's specified range. This could result in inaccurate test results or equipment failure during laboratory use.
Laboratory users who own or use the API JAMES 2AMP devices with the specified batch numbers and UDI/DI codes are affected. Researchers and medical professionals using these devices for testing are most at risk.
Check for the product name 'API JAMES 2AMP' and catalog number 70542. Affected units have specific batch numbers (1009360510) and UDI/DI codes (03573026099893).
Identify the product name, catalog number, batch numbers, and UDI/DI codes to confirm if your device is affected.
The affected batch number is 1009360510.
Check for the catalog number 70542 and UDI/DI code 03573026099893 with batch number 1009360510.
The recall notice does not specify a remedy.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0810-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0810-2023 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.
