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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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