Class 2 Device Recall VIDAS CMV IgG

• Date Initiated by Firm: June 09, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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
• FEI Number: 3002769706
• Recalling Firm/ Manufacturer: bioMerieux; 100 Rodolphe Street; Building 1300; Durham NC 27712
• For Additional Information Contact: Anita M. McClernon, MS, RAC; 919-620-2288
• Manufacturer Reason for Recall: The product may give false positive results.
• FDA Determined Cause: Other
• 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