—#103183

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.

FDA product code: LJC — Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K905787
Affected lot / code info: Catalog number: 30101-01, Lot number 868400501.

Why it was recalled

Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.

Timeline

Recall initiated: 2011-07-08
Posted by FDA: 2011-09-02
Terminated: 2012-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103183. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.