VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
FDA device recall Z-1209-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- Product's decrease in sensitivity may result in false negative results
- Action taken
- On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJC
- Quantity affected
- 2204
- Distribution
- Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, Ch
- Date initiated
- 2003-08-06
- Date posted
- 2003-10-15
- Date terminated
- 2005-05-17
- 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, MODIFICATION (K915884) | Vitek Systems, Inc. | 1992-03-04 |