Z-0252-2013Class II

STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument...

Name: Z-0252-2013 STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument...
Creator: Diagnostica Stago, Inc.
Published: 2012-06-15
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2012-06-15 / Terminated / root cause: software

FDA source

Diagnostica Stago, Inc. began a recall of STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on... on 2012-06-15. FDA classified it as Class II and gives the reason as "Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0252-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Posted: 2012-11-06
Terminated: 2013-07-19
Recalling firm: Diagnostica Stago, Inc.
Product: STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite.
Root cause tag: software
FDA root cause: Software design
Action: Diagnostica Stago sent an Urgent Field Safety Notice dated June 12, 2012, to all affected customers via email return receipt requested on June 15, 2012. Customers were instructed to follow the instructions in the notification and complete the Customer Verification form and return to the Hotline by fax to 973-644-9348. For additional information, customers were instructed to contact the Hotline at 800-725-0607. For questions regarding this recall call 973-631-1200, ext 2044.
Quantity in commerce: 232 units US; 5 units Canada
Distribution: Worldwide Distribution - USA (nationwide) and Canada
Product codes and lots: K082248 D089976 Ref 58104 units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0252-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0252-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06

Product code JPA

K082248Class IISta Satellite Automated Multi-Parameter AnalyzerDiagnostica Stago, Inc. / cleared 2008-12-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)