Recall Z-0039-2008 ยท GKP Instrument, Coagulation, Automated
Diagnostica Stago, Inc.
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
| Date | Oct 11, 2007 (initiated Jul 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | Recall notification letters were mailed to consignees on 7/30/07 by first class mail. |
| Quantity | 41 units installed |
| Distribution | 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 |