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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS CMV IgG

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 Class 2 Device Recall VIDAS CMV IgGsee related information
Date Initiated by FirmJune 09, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 12, 2005
Recall NumberZ-1047-04
Recall Event ID 29330
510(K)NumberK920661 
Product Classification Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
ProductVIDAS CMV IgG Assay
Code Information Catalog #30 204, Lot #782887501
Recalling Firm/
Manufacturer		 bioMerieux
100 Rodolphe Street
Building 1300
Durham NC 27712
For Additional Information ContactAnita M. McClernon, MS, RAC
919-620-2288
Manufacturer Reason
for Recall		The product may give false positive results.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on June 9, 2004.
Quantity in Commerce148 units
DistributionAR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.
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.
510(K) Database510(K)s with Product Code = LFZ
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