Recall Z-0039-2008
Diagnostica Stago, Inc. · initiated July 30, 2007
Product
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Codes / lots: BT7 7016065; BT7 7016067; BT7 7016068; BT7 7016072; BT7 7016074; BT7 7016075; BT8 7016076; BT7 7016078; BT7 7017080; BT7 7016090; BT7 7016091; BT8 7026119; BT8 7026126; BT8 7026127; BT8 7026128; BT8 7026130; BT7 7026134; BT7 7026135; BT7 7026140; BT8 7026146; BT8 7026147; BT8 7026148; BT8 7026149; BT8 7026150; BT7 7026151; BT7 7026152; BT7 7026153; BT7 7026154; BT7 7026155; BT7 7026156; BT7 7026157; BT7 7036164; BT7 7036166; BT7 7036167; BT7 7036168; BT7 7036177; BT7 7036192.
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.
FDA-determined cause: Process design
Action taken
Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
Details
- Recall number
- Z-0039-2008
- Initiated
- July 30, 2007
- Posted by FDA
- October 11, 2007
- Terminated
- December 17, 2007
- Product code
- GKP – Instrument, Coagulation, Automated
- Quantity
- 41 units installed
- Distribution
- Nationwide.
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ