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Health Canada Medical devices

STA – Liquid Anti-Xa

Issued July 31, 2025
Issue
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
Hazard description
Performance
Product
Product name
STA – Liquid Anti-Xa
Reference
ID
RA-77769