Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller Recalled by Diagnostica Stago, Inc. Due to Potential for shorter clotting times in clotting tests...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.
Affected Products
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.
Quantity: 939 US ( 2,810 total worldwide)
Why Was This Recalled?
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Where Was This Sold?
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 notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.
About Diagnostica Stago, Inc.
Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report