Reported Feb 12, 2020 · Terminated
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- Lot codes and dates
- software versions 1.2 and higher
- Amount recalled
- 738 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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