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U.S. Department of Health and Human Services

Class 1 Device Recall VIDAS

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  Class 1 Device Recall VIDAS see related information
Date Initiated by Firm August 06, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on May 17, 2005
Recall Number Z-1209-03
Recall Event ID 26945
510(K)Number K915884  
Product Classification Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) - Product Code LJC
Product VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use
Product Number: 30101
Code Information Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004
Recalling Firm/
100 Rodolphe Street
Building 1300
Durham NC 27712
For Additional Information Contact Anita M. McClernon, MS, RAC
Manufacturer Reason
for Recall
Product's decrease in sensitivity may result in false negative results
FDA Determined
Cause 2
Action On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field.
Quantity in Commerce 2204
Distribution Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA
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 = LJC and Original Applicant = VITEK SYSTEMS, INC.