Diagnostica Stago recalls STA System Control N+P (ref. 00678) due to positive bias in factor VIII/IX testing compared to international standards. Affected lots may cause inaccurate blood test 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 STA System Control N+P (ref. 00678) because it shows positive bias when measuring factor VIII and IX compared to international standards. This could lead to inaccurate blood test results if used in clinical settings.
The control product shows a positive bias when compared to international standards for factor VIII and IX. This means it may give falsely high readings, leading to inaccurate blood test results in clinical settings.
Healthcare professionals using the STA System Control N+P for blood coagulation testing are likely affected. Patients receiving blood tests using this control may be at risk of inaccurate results.
Check for lot numbers 253145, 253416, 253655, 254040, 254206, 254401, 254573, or 254760 on the product label. The product reference code is 00678.
Look for lot numbers 253145, 253416, 253655, 254040, 254206, 254401, 254573, or 254760 on the product label.
The STA System Control N+P (ref. 00678) shows positive bias when compared to international standards for factor VIII and IX, which could lead to inaccurate blood test results.
The recall does not specify a remedy, so contact Diagnostica Stago directly for guidance.
This is a low-risk issue as it affects test accuracy rather than causing physical harm. The hazard does not involve immediate danger to users.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-0738-2020 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-0738-2020 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.
