Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing
STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes a potential reagent contamination without stating any consequence for patient results.
Plain-English summary
The STA Satellite, a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic and immunologic assays, is being recalled across all references and all software versions, UDI-DI 03607450581041 and 03607450581027. The recall covers 3,650 units worldwide, of which 538 are in the United States.
The recall was issued because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated heparin and low molecular weight heparin applications. The FDA classified the action as Class II. The notice does not describe a specific consequence for patient results.
Laboratories operating these analyzers should follow the manufacturer's instructions on affected assays and reagent handling.
The recalled product
- Product
- STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
- Manufacturer
- Diagnostica Stago, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: All references. UDI-DI: 03607450581041
- 03607450581027. All software versions.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Diagnostica Stago, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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