Recall Z-0737-2007 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
| Date | Apr 11, 2007 (initiated Feb 28, 2007) |
| Status | Terminated |
| Reason | The product was erroneously distributed to home users in contrast to its use for healthcare professionals only. |
| Root cause | Other |
| Action | All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07. |
| Quantity | 10 |
| Distribution | Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930454 | BOEHRINGER MANNHEIM COAGUCHEK SYSTEM Boehringer Mannheim Corp., Aug 5, 1993 |
| K962571 | COAGUCHEK PST SYSTEM Boehringer Mannheim Corp., Apr 22, 1997 |
| K974569 | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING Boehringer Mannheim Corp., Jan 9, 1998 |
| K994349 | COAGUCHEK S SYSTEM, MODEL 2138280 Roche Diagnostics Corp., Sep 6, 2000 |