Recall Z-3129-2011 ยท LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
bioMerieux, Inc.
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.
| Date | Sep 2, 2011 (initiated Jul 8, 2011) |
| Status | Terminated |
| Reason | Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients. |
| Root 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 Cu |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905787 | VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST Vitek Systems, Inc., Apr 29, 1991 |