STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- July 30, 2007
- Posted
- October 11, 2007
- Terminated
- December 17, 2007
- Recall Number
- Z-0039-2008
- Quantity
- 41 units installed
- Firm Location
- Parsippany, NJ
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.
Distribution
Nationwide.
Lot / Code Info
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.
Root Cause
Process design
Action Taken
Recall notification letters were mailed to consignees on 7/30/07 by first class mail.