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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS Chlamydia kits

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  Class 2 Device Recall VIDAS Chlamydia kits see related information
Date Initiated by Firm July 08, 2011
Date Posted September 02, 2011
Recall Status1 Terminated 3 on October 23, 2012
Recall Number Z-3129-2011
Recall Event ID 59601
510(K)Number K905787  
Product Classification Enzyme linked immunoabsorbent assay, (chlamydiae group) - Product Code LJC
Product VIDAS Chlamydia test kits

VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay.
Code Information Catalog number: 30101-01, Lot number 868400501.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Benjamin Smith
314-731-8537
Manufacturer Reason
for Recall		 Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.
FDA Determined
Cause 2		 Other
Action bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" letter dated July 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue using and to destroy any of the affected product. The firm advises customers to confirm all positive results obtained with the affected lot number with another method prior to reporting results. An Acknowledgement and Product Replacement form was attached for customers to complete and return to the firm. Customers should contact their local bioMerieux Customer Service representative for questions regarding this notice.
Quantity in Commerce 283 units
Distribution Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.
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.
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