Recall Monitor
Health Products

STA – Liquid Anti-Xa

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: STA – Liquid Anti-Xa
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
STA - Liquid Anti-Xa 4All lots.00311US
STA - Liquid Anti-Xa 8All lots.00322US
STA SatelliteAll lots.58104
STA - Fib 2, Sta - Fibrinogen 5All lots.00674
STA Satellite MaxAll lots.59004

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

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