STA-Owren Koller (Diagnostica Stago) – Clotting Time Inaccuracy (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
Products Sold
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
Diagnostica Stago, Inc. is recalling STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended fo due to Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, PR
Page updated: Jan 10, 2026