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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 IgG see related information
Date Initiated by Firm June 09, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 12, 2005
Recall Number Z-1047-04
Recall Event ID 29330
510(K)Number K920661  
Product Classification Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
Product VIDAS¿ CMV IgG Assay
Code Information Catalog #30 204, Lot #782887501
Recalling Firm/
100 Rodolphe Street
Building 1300
Durham NC 27712
For Additional Information Contact Anita M. McClernon, MS, RAC
Manufacturer Reason
for Recall
The product may give false positive results.
FDA Determined
Cause 2
Action Consignees were notified by letter on June 9, 2004.
Quantity in Commerce 148 units
Distribution AR, 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 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.
510(K) Database 510(K)s with Product Code = LFZ and Original Applicant = VITEK SYSTEMS, INC.