Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
FDA device recall Z-0646-2007 · posted 2007-03-22 · Terminated
Recall details
- Recalling firm
- ThyroTec Inc
- Reason for recall
- Positive control showed little or no positive line.
- Action taken
- On 1/24/07 the recalling firm notified their only customer of the problem. On 2/5/07, the distributor issued recall letters to their customers informing of the problem and the need to destroy the kits. The kits from lot number 02106-06 were returned to the recalling firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- JLW
- Quantity affected
- 484 units
- Distribution
- Nationwide.
- Date initiated
- 2007-01-24
- Date posted
- 2007-03-22
- Date terminated
- 2007-06-04
- Location
- Honey Brook, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THYRO TEST (K030912) | Thryotec | 2003-07-25 |