Class 2 Device Recall VIDAS Chlamydia kits

• Date Initiated by Firm: July 08, 2011
• Date Posted: September 02, 2011
• Recall Status: Terminated 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: 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