Biomerieux recalls API 50 CH Model 50300 due to potential for incorrect organism identification. Affected units include specific lot numbers. Consumers should contact Biomerieux for details.
There is potential to provide an incorrect organism identification.
Biomerieux is recalling its API 50 CH Model 50300 microbiology test devices because they might give wrong organism identification results. This could lead to incorrect medical diagnoses if used in labs.
The devices might provide incorrect organism identification, which could lead to wrong medical diagnoses if used in lab settings. This happens due to potential issues with the identification process.
Laboratory users who own or use the API 50 CH Model 50300 devices are affected. Those working with microbiology tests are most at risk of incorrect results.
Check for the model number '50300' on the device. Affected units include specific lot numbers: 1008679230. The UDI codes (01)03573026087401 and (17)220330 are also indicators.
Look for the model number '50300' on the device to confirm if it's affected.
Reach out to Biomerieux for specific instructions on how to handle affected units.
The API 50 CH Model 50300 devices might provide incorrect organism identification, which could lead to wrong medical diagnoses.
Check the model number and contact Biomerieux for specific instructions on handling affected units.
Yes, affected units include lot number 1008679230.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0243-2022 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0243-2022 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.