Recall Z-1993-2025 ยท PPM General Purpose Reagent
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 performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
| Date | Jun 18, 2025 (initiated May 21, 2025) |
| Status | Open, Classified |
| Reason | Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 939 US ( 2,810 total worldwide) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.