Reported Jun 25, 2025 · Ongoing
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent…
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- STA - Owren Koller
- Model/Catalog Number00360 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
- Lot codes and dates
- UDI(01)13607450003601(11)240331(17)260331(10)270902(241)00360
- Lot Number270902
- Amount recalled
- 939 US ( 2,810 total worldwide)
Where it was sold
Why it was recalled
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
This product could cause temporary or reversible health problems — stop using it.
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