Z-2650-2014Class III

Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R...

Name: Z-2650-2014 Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R...
Creator: Diagnostica Stago, Inc.
Published: 2014-07-18
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2014-07-18 / Terminated / root cause: labeling and UDI

FDA source

Diagnostica Stago, Inc. began a recall of Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the... on 2014-07-18. FDA classified it as Class III and gives the reason as "Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2650-2014
Classification: Class III
Status: Terminated
Initiated: 2014-07-18
Posted: 2014-09-16
Terminated: 2015-01-16
Recalling firm: Diagnostica Stago, Inc.
Product: Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Product code: KFF Assay, Heparin
Reason for recall: Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.
Quantity in commerce: 514 kits
Distribution: Distributed USA (nationwide) and the country of Canada.
Product codes and lots: 510(k) #K111822, Lot #112366, Part # REF 00311US

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2650-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2650-2014	Class III	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-16

Product code KFF

K111822Class IISta(r) - Liquid Anti-Xa, Multi Hep Calibrator, Quality Hnf / Ufh, Quality Hbpm / LmwhDiagnostica Stago, Inc. / cleared 2011-10-26

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)