Chlamydia OIA. For in vitro diagnostic use.
FDA device recall Z-0616-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Thermo Biostar, Incorporated
- Reason for recall
- Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
- Action taken
- All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJC
- Quantity affected
- 56 units
- Distribution
- Nationwide, and to France, New Zealand and Spain.
- Date initiated
- 2003-02-07
- Date posted
- 2003-03-06
- Date terminated
- 2003-05-02
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHLAMYDIA OIA (K951010) | Biostar, Inc. | 1995-10-07 |