Recall archive / FDA device enforcement
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent... — FDA record Z-1993-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 21, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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%
- Classification
- Class II
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 939 US ( 2,810 total worldwide)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1993-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 25, 2025
- Recall initiation date
- May 21, 2025
- Center classification date
- Jun 18, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.