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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:215097

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) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

Official recall number

Z-2475-2025

Evidence summary

Product code
KFF
Recall status
Open, Classified
Event initiated
July 21, 2025
Root cause
Mixed-up of materials/components
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2475-2025

Field note

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