FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
- Recall number
- Z-0039-2008
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2007-07-30
- Posted
- 2007-10-11
- Terminated
- 2007-12-17
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K961579"]
- PMA numbers
- not on file
- Product code
- GKP
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28