STA – Liquid Anti-Xa
Brand(s)
Last updated
Summary
Product
STA – Liquid Anti-Xa
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| STA - Liquid Anti-Xa 4 | All lots. | 00311US |
| STA - Liquid Anti-Xa 8 | All lots. | 00322US |
| STA Satellite | All lots. | 58104 |
| STA - Fib 2, Sta - Fibrinogen 5 | All lots. | 00674 |
| STA Satellite Max | All lots. | 59004 |
Issue
Following internal tests, contamination of STA®-Liquid Anti-Xa by Stago Fibrinogen reagents was identified in UFH and LMWH applications.
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. 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
| Diagnostica Stago Sas |
| 3 Allee Theresa, Asnieres Sur Seine, France, 92600 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77769
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