STA-R blood coagulation analyzer. Catalog Number 57160.
FDA device recall Z-1422-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 215 units
- Distribution
- Units were distributed to clinics and hospitals nationwide.
- Date initiated
- 2005-06-20
- Date posted
- 2005-08-30
- Date terminated
- 2005-08-30
- Location
- Parsippany, NJ
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