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.
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Diagnostica Stago recalls Owren Koller buffer solution (model 00360) because it may cause clotting tests to show shorter clotting times, potentially overestimating results by up to 1%. This could lead to inaccurate medical test results if used in coagulation testing.
The buffer solution may cause clotting tests to show shorter clotting times than actual, leading to an overestimation of results by up to 1%. This could result in incorrect medical decisions if the test is used for critical coagulation assessments.
Users of Owren Koller buffer solution for coagulation tests are affected. Healthcare professionals using this product in clinical settings are most at risk due to potential inaccuracies in test results.
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.
Verify the model number and UDI on the product label to confirm if it is affected.
The recalled model number is 00360.
It may cause clotting tests to show shorter clotting times, potentially overestimating results by up to 1%.
Check the product label for the model number and UDI to confirm if it is affected. No specific action is required beyond verification.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1993-2025 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-1993-2025 from Diagnostica Stago. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
