Diagnostica Stago, Inc.: 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 perfo

Hazard

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

Details from the source

Reason for recall: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% Distribution: 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. Quantity: 939 US ( 2,810 total worldwide) Lot/code info: UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.

UPC codes

13607450003601

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.