VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for
FDA device recall Z-3129-2011 · posted 2011-09-02 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJC
- Quantity affected
- 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.
- Date initiated
- 2011-07-08
- Date posted
- 2011-09-02
- Date terminated
- 2012-10-23
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST (K905787) | Vitek Systems, Inc. | 1991-04-29 |