Recall Z-1200-2017 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
BioMerieux SA
VIDAS 3 software v. 1.1.4
| Date | Feb 14, 2017 (initiated Jan 11, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Software in the Use Environment |
| Action | Consignees were notified via letter on January 11th, 2017. |
| Quantity | 1161 units |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.