• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS 3 software v. 1.1.4

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall VIDAS 3 software v. 1.1.4 see related information
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/
BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information Contact Jeff Scanlan
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

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.