Official recall record

STA – Liquid Anti-Xa

Health Canada — Medical Devices · 2025-07-25 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-07-25
Last updated (per notice): 2025-07-31
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Following internal tests, contamination of STA®-LIQUID ANTI-Xa by Stago Fibrinogen reagents was identified in UFH and LMWH applications on STA SATELLITE® or STA SATELLITE MAX® analyzers. Contamination occurs when one or more tests with the STA®-Fibrinogen 5 reagent are performed before the STA®-LIQUID ANTI-Xa test for heparin monitoring on an STA SATELLITE® or STA SATELLITE MAX® analyzer. This contamination causes an underestimation of heparin levels which could lead to a heparin treatment change and a subsequent overdose risk for the patient. Recall start date: July 21, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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