Biomerieux Vidas 3 recall: Software Issue
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Why was Biomerieux Vidas 3 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
software versions 1.2 and higher
- Product
- BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- Recalling firm
- Biomerieux Inc
- Quantity
- 738 units
- Distribution
- US
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)