FDA-Device2020-02-12Class II

BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

Biomerieux Inc
Hazard

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.

Sold states
US
Affected count
738 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2020

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