STA-Owren Koller Buffer Solution Recall Due to Clotting Time Concerns
Diagnostica Stago is recalling STA-Owren Koller buffer solution (Lot 270902) because it may produce shorter clotting times in certain tests, potentially leading to a 1% overestimate of clotting results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall where the source text explicitly states no illnesses or injuries have been reported. The hazard is a potential analytical error (approximately 1% overestimate) in coagulation testing with theoretical consequences, making it a precautionary/labeling-type concern rather than an active safety incident.
Plain-English summary
Diagnostica Stago, Inc. is recalling STA-Owren Koller buffer solution, Model/Catalog Number 00360, Lot Number 270902. The product is intended for use as a diluent for reagents and human plasmas in coagulation tests performed with STA-R, STA Compact, STA Satellite, and ST art analyzer families.
The recall is due to a potential for shorter clotting times in clotting tests that include dilution, which may result in a possible overestimate of approximately 1% in clotting results.
Approximately 939 units were distributed in the United States in October and November 2024. The affected lot was also distributed internationally to Canada and to two distributors in US Territories: MedPharm Corp in Guam and Isla Lab Products in Puerto Rico.
Healthcare facilities and laboratories using this lot should contact Diagnostica Stago, Inc. for instructions regarding the recall and testing corrections that may be needed for any affected patient results.
The recalled product
- Product
- 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.
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- analytical-error
- clotting-test-accuracy
Distribution
Distribution scope not specified by the agency.
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