Diagnostica Stago recalls Owren Koller buffer solution (model 00360) due to potential shorter clotting times in tests, which could overestimate results by up to 1%. Affected units sold with specific UDI and lot numbers.
“Diagnostica Stago Owren Koller Buffer Solution Recall: Shorter Clotting Times Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52244-diagnostica-stago-owren-koller-buffer-solution-recall-shorter-clotting-times. Based on FDA recall #Z-1993-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2025%22&limit=1).
The FDA announced on May 21, 2025, that Diagnostica Stago, Inc. is voluntarily recalling its STA - Owren-Koller buffer solution due to potential shorter clotting times in tests. The agency issued recall number Z-1993-2025 for the Class II device.
How to tell if you have it
Brand: Diagnostica Stago
Product: STA - Owren-Koller
Model/Catalog Number: 00360
UPC: 13607450003601
Lot Number: 270902
Distribution: US states, Canada, Guam, and Puerto Rico in October and November 2024
The hazard
The buffer solution may cause potential shorter clotting times in clotting tests that have a dilution. This defect can lead to a possible overestimate of around 1% in results.
Context
GovInfoNow's records show Diagnostica Stago, Inc. has had 12 other recalls on record since October 25, 2017. Recent brand recalls include the STA Staclot Protein S Recall on July 29, 2026, and the STA Liatest D-Di recall on February 5, 2026. Other recent recalls of similar products include the HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (November 18, 2025), the Accriva VerifyNow PRUTest Platelet Test Recall (October 21, 2025), and the Beckman Coulter DxH Diluent Recall (November 10, 2025).
How to tell if you have this one
Check for the model number 00360 on the product label. The product was sold with a specific UDI (01)13607450003601(11)240331(17)260331(10)270902(241)00360 and lot number 270902.
Brand
Diagnostica Stago
Product
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number and UDI on the product label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1993-2025 (May 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1993-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.