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FDAMay 21, 2025device

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 recorded by the U.S. Food & Drug Administration.

The hazard

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

What to do

FDA enforcement status: Ongoing

Brands named

diagnostica stagodiagnostica

UPCs

13607450003601

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear