Stago recalls STA Deficient VIII product code 00725 due to risk of false high factor VIII results from cross-contamination. Affected units include specific STA-R and STA Compact analyzers with listed product codes and software versions.
A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
Stago is recalling a specific plasma product (STA Deficient VIII, product code 00725) because it can cause false high factor VIII results in blood tests. This risk affects patients using certain blood analyzers, potentially leading to incorrect treatment decisions.
The plasma product can cause cross-contamination on Stago analyzers, leading to falsely elevated factor VIII levels in test results. This may result in incorrect blood clotting assessments and potentially inappropriate treatment decisions.
Patients using Stago's STA Deficient VIII plasma product for factor VIII testing with specific analyzers (STA-R Max, STA-R Evolution, STA Compact Max, or STA Compact) are affected. Those with the listed product codes and software versions are most at risk.
Check for product code 00725 on the STA Deficient VIII plasma. Affected analyzers include STA-R Max (product codes 58989, 58990), STA-R Evolution (product codes 58986, 58987, 58988), STA Compact Max (product codes 59026, 59027), and STA Compact (product codes 58978, 58979).
Look for product code 00725 on the STA Deficient VIII plasma product.
Confirm if your analyzer is one of the affected models (STA-R Max, STA-R Evolution, STA Compact Max, or STA Compact) with the listed product codes.
The product is not safe for use as recalled. It can cause false high factor VIII results, which may lead to incorrect treatment decisions.
Check if you have the product code 00725 and the affected analyzers. If so, contact Stago for software updates or other remedies.
No immediate stop is required, but you should check for the product code and affected analyzers to ensure accurate test results.
We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1699-2020 — Stago Stago Hello, I own a Stago that is covered by recall Z-1699-2020 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.
