Biomerieux recalls BACT/ALERT VIRTUO system B Units with R2.0 firmware due to potential calibration issues. Affected units may show anomalies if calibration standards aren't properly repositioned during service. Contact for remedy details.
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 system B Units with R2.0 firmware because improper calibration standards placement during service could cause system anomalies. This affects laboratory users who rely on the system for microbial detection.
The R2.0 firmware allows technicians to move calibration standards during service. If these standards aren't returned to their correct positions, the system may show incorrect results or anomalies.
Laboratory users who operate the BACT/ALERT VIRTUO system with R2.0 firmware are most at risk. The recall applies to specific B Units with the mentioned firmware version.
Check for the BACT/ALERT VIRTUO system B Unit with firmware version R2.0. Affected units have serial numbers listed in the recall notice.
Verify the firmware version on your BACT/ALERT VIRTUO system B Unit. If it's R2.0, it may be affected.
The R2.0 firmware allows technicians to relocate calibration standards during service. If not properly repositioned, the system may show anomalies.
No. The recall does not require immediate discontinuation. Users can continue using the system as long as calibration standards are correctly repositioned after service.
Check for the BACT/ALERT VIRTUO system B Unit with firmware version R2.0. Affected units have specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0229-2019 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0229-2019 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.
