Recall Z-1993-2025— Diagnostica Stago, Inc.
Class II · Ongoing
Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2025-05-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%.
- Recalling firm
- Diagnostica Stago, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-21
- Firm location
- Parsippany, NJ, United States
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%
Data sourced from openFDA. This site is unofficial and independent of the FDA.