Diagnostica Stago recalls Unicalibrator (ref. 00675) due to positive bias in factor VIII/IX measurements compared to international standards, affecting lab results.
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Diagnostica Stago is recalling its Unicalibrator (ref. 00675) because it consistently shows higher results than the international standard for factor VIII and IX tests. This could lead to inaccurate blood clotting measurements, potentially affecting patient treatment decisions.
The Unicalibrator shows higher levels of factor VIII and IX than the international standard, causing lab results to be too high. This positive bias can lead to incorrect blood clotting assessments, potentially affecting patient treatment decisions.
Lab users who purchased the Unicalibrator with lot numbers 253180, 253964, 254721, or 255108 are affected. Patients relying on these tests for blood clotting assessments may be at risk of inaccurate results.
Check for lot numbers 253180, 253964, 254721, or 255108 on the Unicalibrator's packaging. The product is identified by reference number 00675 and unique identifiers starting with (01)13607450006756.
Look for lot numbers 253180, 253964, 254721, or 255108 on the Unicalibrator's packaging.
The Unicalibrator shows higher levels of factor VIII and IX than the international standard, causing lab results to be too high.
Check for lot numbers 253180, 253964, 254721, or 255108 on the packaging. The product is identified by reference number 00675.
The recall does not require stopping use; the product is safe for continued use but may produce inaccurate results.
We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-0737-2020 — Stago Stago Hello, I own a Stago that is covered by recall Z-0737-2020 from 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.
