Recall Z-0928-2020— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2019-10-22, terminated 2024-08-06. It names one FDA 510(k) clearance: K141133. Product: BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation. Reason: 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..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-22
- Terminated
- 2024-08-06
- Firm location
- Hazelwood, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.