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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 VIDASsee related information
Date Initiated by FirmAugust 06, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on May 17, 2005
Recall NumberZ-1209-03
Recall Event ID 26945
510(K)NumberK915884 
Product Classification Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) - Product Code LJC
ProductVIDAS 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/
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		Product's decrease in sensitivity may result in false negative results
FDA Determined
Cause 2		Other
ActionOn 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 Commerce2204
DistributionNationwide 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 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 = LJC
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