The Recall Desk
HighFDA (Devices)·Z-2475-2025·Announced 2025-09-03

STA-Liquid Anti-Xa 8 Laboratory Test Kit Recall Due to Potential Reagent Contamination

Diagnostica Stago is recalling STA-Liquid Anti-Xa 8 test kits used to measure heparin levels in blood due to potential contamination by Fibrinogen reagents. No patient harm has been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a clinical laboratory test kit with potential for contamination that could affect test accuracy and heparin level measurements. No patient illnesses, injuries, or deaths have been reported. Per the rubric, risk-of-harm medical device recalls without reported injury are scored at 3 (High).

Plain-English summary

Diagnostica Stago, Inc. is recalling the STA-Liquid Anti-Xa 8 test kit (Model 00322US) used in clinical laboratories to measure heparin levels in patients receiving blood-thinning therapy. The test is used with STA-R, STA Compact, and STA Satellite analyzers.

The FDA determined there is a potential for contamination of the test kit by Stago Fibrinogen reagents. This contamination could affect test accuracy and result in incorrect heparin level measurements, potentially impacting treatment decisions for patients on anticoagulation therapy.

The affected product has been distributed worldwide and to multiple U.S. states including Alabama, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Vermont, Wisconsin, and Wyoming. Approximately 126,200 units have been distributed overall, with 125,900 units in the U.S.

Healthcare facilities and clinical laboratories using this product should contact Diagnostica Stago, Inc. for instructions on affected lot identification and remediation. No patient harm has been reported.

The recalled product

Product
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. 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) heparin
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device
Hazard
  • reagent-contamination
  • test-accuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model/Catalog Number: 00322US. UDI-DI: 03607450011791

Distribution

Distributed nationwide across the United States.

Related recalls

Same category