VIDAS 3 software v. 1.1.4
FDA device recall Z-1200-2017 · posted 2017-02-14 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- 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.
- Action taken
- Consignees were notified via letter on January 11th, 2017.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- LFZ
- Quantity affected
- 1161 units
- Distribution
- U.S.
- Date initiated
- 2017-01-11
- Date posted
- 2017-02-14
- Date terminated
- 2017-08-28
- Location
- Marcy L'Etoile, France
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