Recall Z-1200-2017— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2017-01-11, terminated 2017-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: VIDAS 3 software v. 1.1.4. Reason: During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-11
- Terminated
- 2017-08-28
- Firm location
- Marcy L'Etoile, N/A, France
Product description
VIDAS 3 software v. 1.1.4
Reason for recall
During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
Data sourced from openFDA. This site is unofficial and independent of the FDA.