Lower riskMedical device recall · FDA · Published July 15, 2020
Qiagen QIAstat-Dx SARS-CoV-2 Panel Recall: False Positive Risk for Influenza A
Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 due to increased false positives for Influenza A, risking incorrect treatment and delayed diagnosis. Affected units include specific lots.
There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
Qiagen is recalling its QIAstat-Dx Respiratory SARS-CoV-2 Panel (REF 691223) because it can produce false positive results for Influenza A. This may lead to unnecessary antiviral use or missed diagnoses of other conditions. The recall affects specific production lots sold under FDA EUA. Read more at govinfonow.com/recall/64710-qiagen-qiastat-dx-sars-cov-2-panel-recall-false-positive.
“Qiagen QIAstat-Dx SARS-CoV-2 Panel Recall: False Positive Risk for Influenza A.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64710-qiagen-qiastat-dx-sars-cov-2-panel-recall-false-positive. Based on FDA recall #Z-2938-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2938-2020%22&limit=1).
The FDA announced on July 15, 2020, that Qiagen Sciences LLC is recalling the QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 due to an increased rate of potential false positive results for the Influenza A target. The agency classified this as a Class II recall.
The recall addresses an increased rate of potential false positive results for the Influenza A (no subtype) target. This error may lead to inappropriate antiviral use, erroneous or delayed differential diagnosis, and missing of an alternative diagnosis.
Context
GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Other recent recalls of similar products include the QIAstat-Dx Respiratory Panel Plus recall (March 12, 2025), the QIAcube Connect MDx Recall (June 3, 2024), and the EZ2 Connect MDx-IVD Recall (March 4, 2024). Other recent recalls of similar products include the Quidel QuickVue Strep A Test Recall (April 6, 2026), the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and the BioFire Spotfire Respiratory Panel Recall (April 1, 2026).
How to tell if you have this one
Check the product lot number on the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Affected lots include 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, and 166029508.
Brand
Qiagen
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number on the QIAstat-Dx Respiratory SARS-CoV-2 Panel to see if it matches the affected lots listed.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, California, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2938-2020 (July 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2938-2020 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.