Biomerieux recalls VIDAS 3 compact immunoanalyzer with software versions 1.2+ due to expired calibration causing false test results. Affected units may need recalibration.
Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
Biomerieux is recalling its VIDAS 3 immunoanalyzer devices with software versions 1.2 and higher because the calibration system may show expired calibrations as valid, leading to false test results. This could affect medical testing accuracy if the device is used without proper calibration checks.
The software incorrectly displays expired calibration dates as valid, causing the device to compute test results without warning. This means false results may occur even when the calibrations are actually expired, potentially affecting medical testing accuracy.
Healthcare facilities using the VIDAS 3 immunoanalyzer with software versions 1.2 and higher are most at risk. Patients relying on these devices for medical testing could receive inaccurate results if the calibration issue persists.
Check if your device has the name 'BIOMERIEUX VIDAS 3' and software version 1.2 or higher. The recall covers devices sold with full traceability and automation features.
Verify your device's software version to confirm it is 1.2 or higher.
The software incorrectly shows expired calibration dates as valid, causing false test results without warning.
No, but you should check the software version and contact Biomerieux if you have version 1.2 or higher.
The official recall does not specify a fix; you should contact Biomerieux for further guidance.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0928-2020 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0928-2020 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.
