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.

Recall Insight

This FDA Devices action (record #Z-1993-2025) was formally reported on June 25, 2025, with the manufacturer initiating the action on May 21, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Diagnostica Stago, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records indicate 939 US ( 2,810 total worldwide) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% Distribution data in the federal record shows the product reached: 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 Territo…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.