Qiagen recalls PIK3:3CA RGQ PCR Kit (23) US IVD product due to potential false positive results for breast cancer mutation testing. Affected kits may misidentify patients for PIQRAY treatment.
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
“Qiagen PIK3CA RGQ PCR Kit Recall: False Mutation Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63674-qiagen-pik3ca-rgq-pcr-kit-recall-false-mutation-results-risk. Based on FDA recall #Z-0937-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0937-2021%22&limit=1).
Qiagen Sciences LLC recalled the therascreen PIK3CA RGQ PCR Kit (23) US IVD product due to potential false positive results for the Q546R mutation, according to the FDA. The Food and Drug Administration announced the recall on December 11, 2020.
How to tell if you have it
Brand: Qiagen
Product: therascreen PIK3CA RGQ PCR Kit (23) US IVD product
REF: 873121
Lots: All lots
Quantity: 575 kits US
The hazard
The kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
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 Qiagen QIAstat-Dx Respiratory Panel Plus (March 12, 2025), Qiagen QIAcube Connect MDx Recall (June 3, 2024), and Qiagen EZ2 Connect MDx-IVD Recall (March 4, 2024). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), Foundation Medicine Sequencing Agent SEQ0067 Recall (March 20, 2026), and Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).
How to tell if you have this one
The PIK3CA RGQ PCR Kit (23) is a US IVD product sold for breast cancer mutation testing. All lots are affected, so any kit with this product name is recalled.
Brand
Qiagen
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Review the lot number on the kit to confirm it is affected (all lots are recalled).
Where it went and when
Where it was distributed
Distributed in 9 states.
Listed by the agency
Not listed
FDA distribution: “CA, IN, MI, MN, NC, NJ, NM, OH, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Indiana, Michigan, Minnesota, New Jersey, New Mexico, North Carolina, Ohio, Texas.
Recall timeline
FDA terminated this recall 16 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-0937-2021 (December 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0937-2021 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.