STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
FDA device recall Z-0039-2008 · posted 2007-10-11 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.
- Action taken
- Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 41 units installed
- Distribution
- Nationwide.
- Date initiated
- 2007-07-30
- Date posted
- 2007-10-11
- Date terminated
- 2007-12-17
- 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 |