Lower risk Medical device recall · FDA · Published March 4, 2020

Stago STA Deficient VIII Recall: Risk of False Factor VIII Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1699-2020Medical device Stago ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmDiagnostica Stago, Inc.5 Century Dr · Parsippany, NJ 07054-4607

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/65721-stago-sta-deficient-viii-recall-risk-of-false-factor-viii.

Source Summary by GovInfoNow · govinfonow.com/recall/65721-stago-sta-deficient-viii-recall-risk-of-false-factor-viii · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1699-2020

Cite this page

“Stago STA Deficient VIII Recall: Risk of False Factor VIII Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65721-stago-sta-deficient-viii-recall-risk-of-false-factor-viii. Based on FDA recall #Z-1699-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2020%22&limit=1).

The FDA announced on March 4, 2020, that Diagnostica Stago, Inc. is recalling STA - Deficient VIII due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels. The agency issued recall number Z-1699-2020 for the immuno-depleted human plasma product.

How to tell if you have it

Brand: Stago
Product: STA - Deficient VIII, Product Code: 00725
Units affected: 3,225 units

The hazard

The recall addresses a risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments. This contamination may cause clotting times to be shortened, which can result in factor VIII levels being reported as falsely increased.

Context

GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since 2026-07-29. Other recent recalls of similar products include the Fujirebio Lumipulse pTau 217 Plasma Controls Recall (2025-12-11), the Tosoh ST AIA-Pack Testosterone Recall (2026-06-12), and the Vivoo Protein Test Recall (2025-11-22).

How to tell if you have this one

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).

Brand
Stago
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for product code 00725 on the STA Deficient VIII plasma product.
Verify Analyzer Model
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.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Mar 4, 2020Firm started the recall
Apr 10, 2020FDA classified it Class II
Apr 22, 2020Published in FDA’s Enforcement Report
Nov 10, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the product immediately?

No immediate stop is required, but you should check for the product code and affected analyzers to ensure accurate test results.

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Link to this recall

<a href="https://govinfonow.com/recall/65721-stago-sta-deficient-viii-recall-risk-of-false-factor-viii">Stago STA Deficient VIII Recall: Risk of False Factor VIII Results (GovInfoNow)</a>

Where this comes from

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-1699-2020 (March 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1699-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.