Recall Z-0813-03 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Roche Diagnostics Corp.
CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
| Date | May 14, 2003 (initiated Mar 12, 2003) |
| Status | Terminated |
| Reason | High frequency signals from other medical or communications equipment will result in a variable positive bias in test results. |
| Root cause | Other |
| Action | Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory. |
| Quantity | 1322 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983892 | COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P Roche Diagnostics/Boehringer Mannheim GmbH, Apr 13, 1999 |