STA – Liquid Anti-Xa
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 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
Additional information
Details
| Diagnostica Stago Sas |
| 3 Allee Theresa, Asnieres Sur Seine, France, 92600 |
Get notified
Receive emails about new and updated recall and safety alerts.