Anti-Xa test kits recalled over potential contamination by fibrinogen reagents
STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 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
STA-Liquid Anti-Xa 8, model and catalog number 00322US, UDI-DI 03607450011791, is being recalled. The kits are intended for use with STA-R, STA Compact and STA Satellite analyzers for the quantitative determination of plasma levels of unfractionated heparin and low molecular weight heparin. The recall covers 126,200 units, of which 125,900 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 holding these kits should follow the manufacturer's instructions on affected assays and reagent handling.
The recalled product
- Product
- STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH)…
- 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 (1)
- Model/Catalog Number: 00322US. UDI-DI: 03607450011791
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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