Z-1993-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2025
- Initiation Date
- May 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 939 US ( 2,810 total worldwide)
Product Description
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.
Reason for Recall
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Distribution Pattern
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.
Code Information
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.