Z-1081-04

STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set...

Name: Z-1081-04 STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set...
Creator: Diagnostica Stago, Inc.
Published: 2002-12-20
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2002-12-20 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of... on 2002-12-20. The reason FDA records is "Incorrect assay ranges on the assay value insert for Heparin Control 5". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1081-04
Status: Terminated
Initiated: 2002-12-20
Posted: 2004-07-20
Terminated: 2004-07-14
Recalling firm: Diagnostica Stago, Inc.
Product: STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.
Product code: JOX Analyzer, Heparin, Automated
Reason for recall: Incorrect assay ranges on the assay value insert for Heparin Control 5.
FDA root cause: Other
Action: Manufacturer notified Diagnostica Stago, US of the problem in December 2002. Diagnostica Stago sent a letter dated 12/20/2002 along with replacement insert sheet and effectiveness check forms to all consignees.
Quantity in commerce: 523
Distribution: Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals.
Product codes and lots: Lot number 02019. Exp. 1/31/2004.

Product code JOX

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)