Recall Z-0720-03 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Roche Diagnostics Corp.
CoaguChek PT test strips, sold in 12 pack.
| Date | Apr 10, 2003 (initiated Feb 20, 2003) |
| Status | Terminated |
| Reason | Discrepancy between INR and the % Quick displayed on the meter. |
| Root cause | Other |
| Action | Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick. |
| Quantity | 11412 containers |
| Distribution | Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974569 | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING Boehringer Mannheim Corp., Jan 9, 1998 |