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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:214063

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.

Official recall number

Z-1993-2025

Evidence summary

Product code
PPM
Recall status
Open, Classified
Event initiated
May 21, 2025
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1993-2025

Field note

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