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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS 3 software v. 1.1.4

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 Class 2 Device Recall VIDAS 3 software v. 1.1.4see related information
Date Initiated by FirmJanuary 11, 2017
Date PostedFebruary 14, 2017
Recall Status1 Terminated 3 on August 28, 2017
Recall NumberZ-1200-2017
Recall Event ID 76281
Product Classification Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
ProductVIDAS 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 ContactJeff 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
ActionConsignees were notified via letter on January 11th, 2017.
Quantity in Commerce1161 units
DistributionU.S.
Total Product Life CycleTPLC Device Report
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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