Recall Z-0812-2007 ยท GKP Instrument, Coagulation, Automated
Diagnostica Stago, Inc.
STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France
| Date | May 16, 2007 (initiated Jan 18, 2007) |
| Status | Terminated |
| Reason | Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors. |
| Root cause | Other |
| Action | A recall notification has not been sent. The firm did issue a technical bulletin to their representatives.--Update: based on FDA input the firm issued a Recall Letter to all users dated May 25, 2007 |
| Quantity | 693 units |
| Distribution | Product was distributed to hospitals and laboratories nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co., Jul 10, 1996 |