Z-0039-2008

STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic

Name: Z-0039-2008 STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic
Creator: Diagnostica Stago, Inc.
Published: 2007-07-30
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2007-07-30 / Terminated / root cause: manufacturing process

FDA source

Diagnostica Stago, Inc. began a recall of STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic on 2007-07-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0039-2008
Status: Terminated
Initiated: 2007-07-30
Posted: 2007-10-11
Terminated: 2007-12-17
Recalling firm: Diagnostica Stago, Inc.
Product: STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Product code: GKP Instrument, Coagulation, Automated
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
Quantity in commerce: 41 units installed
Distribution: Nationwide.
Product codes and 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.

Product code GKP

K961579Class IISta Compact Automated Multi-Parametric AnalyzerAmerican Bioproducts Co. / cleared 1996-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)