Qiagen recalls Therascreen EGFR RGQ PCR Kit (24) due to rare false mutation positive results from fluorescence artefacts. All lots affected. No remedy specified.
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
“Qiagen Therascreen EGFR RGQ PCR Kit Recall: False Mutation Positives Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65459-qiagen-therascreen-egfr-rgq-pcr-kit-recall-false-mutation-positives. Based on FDA recall #Z-2290-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2290-2020%22&limit=1).
Qiagen Sciences LLC recalled the therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121, due to a risk of false mutation positive results from fluorescence artefacts. The Food and Drug Administration announced the Class II recall on April 8, 2020.
How to tell if you have it
Brand: Qiagen
Product: therascreen EGFR RGQ PCR Kit (24)
Reference Number: REF 870121
Lots: All lots
The hazard
The recall addresses the risk of false mutation positive results in rare cases caused by a fluorescence artefact. In these instances, controls pass correctly while the mutation assay yields an incorrect valid mutation positive result.
Context
GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Recent similar recalls include the Qiagen QIAstat-Dx Respiratory Panel Plus recall (March 12, 2025) and the Qiagen QIAcube Connect MDx Recall (June 3, 2024). Other recent recalls of similar products include the Exploro Fertility Test Recall (November 22, 2025), the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).
How to tell if you have this one
Check for the Therascreen EGFR RGQ PCR Kit (24) with Reference Number REF 870121. All lots of this product are affected by the recall.
Brand
Qiagen
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the kit by its name and reference number to confirm it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US 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 14 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-2290-2020 (April 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2290-2020 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.