Date Initiated by Firm |
January 11, 2017 |
Date Posted |
February 14, 2017 |
Recall Status1 |
Terminated 3 on August 28, 2017 |
Recall Number |
Z-1200-2017 |
Recall Event ID |
76281 |
Product Classification |
Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
|
Product |
VIDAS 3 software v. 1.1.4 |
Code Information |
REF: #412590, Lot: Software version 1.1.4 |
Recalling Firm/ Manufacturer |
BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
|
For Additional Information Contact |
Jeff Scanlan 314-731-8694
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Software in the Use Environment |
Action |
Consignees were notified via letter on January 11th, 2017. |
Quantity in Commerce |
1161 units |
Distribution |
U.S. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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