STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France
FDA device recall Z-0812-2007 · posted 2007-05-16 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 693 units
- Distribution
- Product was distributed to hospitals and laboratories nationwide.
- Date initiated
- 2007-01-18
- Date posted
- 2007-05-16
- Date terminated
- 2007-12-10
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K961579) | American Bioproducts Co. | 1996-07-10 |