BioMérieux recalls BACT/ALERT VIRTUO system units with R2.0 firmware due to potential calibration issues affecting microbial detection accuracy. Affected units have specific serial numbers and were sold with this firmware version.
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.
BioMérieux is recalling BACT/ALERT VIRTUO microbial detection systems with R2.0 firmware because improper calibration could cause false results. This affects lab equipment used for testing blood and body fluids for infections.
The R2.0 firmware allows calibration standards to be moved during service. If these standards aren't returned to their correct positions, the system might give inaccurate test results, potentially affecting infection detection.
Healthcare facilities using the BACT/ALERT VIRTUO system with R2.0 firmware for microbial testing are most at risk. This recall impacts lab equipment that detects infections in blood and body fluids.
Check for the BACT/ALERT VIRTUO system with R2.0 firmware. Affected units have specific serial numbers and were sold with this firmware version. The product reference number is 411660.
Verify the firmware version on your BACT/ALERT VIRTUO system. If it's R2.0, it's affected.
Reach out to BioMérieux for guidance on whether your system needs calibration adjustments.
The R2.0 firmware allows calibration standards to be relocated during service. If not properly reset, it may cause inaccurate test results.
Check for the BACT/ALERT VIRTUO system with R2.0 firmware. Affected units have specific serial numbers and reference number 411660.
No. The recall involves a calibration adjustment, not immediate safety risks. You can continue using the system with proper calibration steps.
We’ve drafted a message you can send BioMérieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0228-2019 — BioMérieux BioMérieux Hello, I own a BioMérieux that is covered by recall Z-0228-2019 from BioMérieux. 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.
