Recall Z-0646-2007 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ThyroTec Inc
Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
| Date | Mar 22, 2007 (initiated Jan 24, 2007) |
| Status | Terminated |
| Reason | Positive control showed little or no positive line. |
| Root cause | Other |
| Action | 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. |
| Quantity | 484 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030912 | THYRO TEST Thryotec, Jul 25, 2003 |