Z-1422-05

STA-R blood coagulation analyzer. Catalog Number 57160

Name: Z-1422-05 STA-R blood coagulation analyzer. Catalog Number 57160
Creator: Diagnostica Stago, Inc.
Published: 2005-06-20
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2005-06-20 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of STA-R blood coagulation analyzer. Catalog Number 57160 on 2005-06-20. The reason FDA records is "Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1422-05
Status: Terminated
Initiated: 2005-06-20
Posted: 2005-08-30
Terminated: 2005-08-30
Recalling firm: Diagnostica Stago, Inc.
Product: STA-R blood coagulation analyzer. Catalog Number 57160.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.
FDA root cause: Other
Action: Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned.
Quantity in commerce: 215 units
Distribution: Units were distributed to clinics and hospitals nationwide.
Product codes and lots: All units distributed under Catalog Number 57160.

Product code JPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)