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.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- May 21, 2025
- Posted
- June 18, 2025
- Recall Number
- Z-1993-2025
- Quantity
- 939 US ( 2,810 total worldwide)
- Firm Location
- Parsippany, NJ
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.
Lot / Code Info
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
Root Cause
Under Investigation by firm
Action Taken
Diagnostica Stago, Inc. notified consignees on 05/21/2025 via email. Consignees were instructed to review inventory for any affected units, stop using the affected lot and destroy it, and complete and return the acknowledgement form.