Diagnostica Stago, Inc. STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Diagnostica Stago, Inc. is recalling STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. due to Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by ei. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026