Biomerieux recalls BACT/ALERT VIRTUO microbial detection systems with R2.0 firmware in China. Calibration standards may become misaligned, causing false results if not reset properly.
The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.
Biomerieux is recalling BACT/ALERT VIRTUO microbial detection systems with R2.0 firmware from China. If calibration standards aren't reset after service, the system might give false results.
The firmware update allows calibration standards to be moved during service. If these standards aren't returned to their proper positions, the system may produce false results, but it doesn't cause physical harm.
Users of the BACT/ALERT VIRTUO system with R2.0 firmware in China. Lab technicians and healthcare workers using this system are most at risk.
Check for the BACT/ALERT VIRTUO system with R2.0 firmware from China. Product includes reference number 419947 and serial numbers like 03573026509538.
Ensure calibration standards are reset to their designated locations after any service.
No, the recall is for potential false results, not physical harm. The system remains safe to use if calibration standards are reset.
Check for the BACT/ALERT VIRTUO system with R2.0 firmware from China, which has reference number 419947 and serial numbers like 03573026509538.
Ensure calibration standards are reset to their proper positions after any service to prevent 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-0230-2019 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0230-2019 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.
