Fibrinogen test kits recalled over potential cross-contamination in heparin assays
STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.
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
STA-Fibrinogen 5, model and catalog number 00674, UDI-DI 13607450006749, is being recalled. The kit is intended for use with analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma. The recall covers 829,800 units, of which 245,200 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 - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- reagent-contamination
- in-vitro-diagnostic
- class-ii
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: 00674. UDI-DI: 13607450006749
Distribution
Distributed nationwide across the United States.
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