Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent f…

Recall date

May 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1993-2025

FDA classification

Class II

Brand / firm

Diagnostica Stago, Inc.

Sold / distributed

The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be n…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.