Recall Z-1422-05 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Diagnostica Stago, Inc.
STA-R blood coagulation analyzer. Catalog Number 57160.
| Date | Aug 30, 2005 (initiated Jun 20, 2005) |
| Status | Terminated |
| Reason | Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process. |
| Root cause | Other |
| Action | Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned. |
| Quantity | 215 units |
| Distribution | Units were distributed to clinics and hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.