Qiagen recalls KRAS RGQ PCR Kit (24) Model REF 870021 due to false positive/negative results for KRAS mutations, potentially invalidating test outcomes.
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Qiagen is recalling its KRAS RGQ PCR Kit (24) with model number REF 870021 because it can produce false positive or negative results for KRAS mutations. This could lead to incorrect test outcomes, which might affect medical decisions. Read more at govinfonow.com/recall/61028-qiagen-kras-pcr-kit-recall-false-mutation-results-risk.
“Qiagen KRAS PCR Kit Recall: False Mutation Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61028-qiagen-kras-pcr-kit-recall-false-mutation-results-risk. Based on FDA recall #Z-0951-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0951-2022%22&limit=1).
The FDA announced on Feb. 25, 2022, that Qiagen Sciences LLC voluntarily recalled the therascreen KRAS RGQ PCR Kit (24) due to potential false positive or negative mutation results. The agency issued recall number Z-0951-2022 for the Class II device.
How to tell if you have it
therascreen KRAS RGQ PCR Kit (24)
REF 870021
UPC 04053228002048
The hazard
The kit may produce false positive or false negative G12C (12CYS) mutation results for the KRAS Mutation Status because Flags/Warnings may invalidate the result for one or more individual mutation target. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Recent similar product recalls include the Biomerieux VITEK 2 AST-N461 Test Kit (July 24, 2026), the Biomerieux VITEK 2 AST-N447 Kit (June 4, 2026), and the Diagnostica Stago Asserachrom HPIA Kit (Dec. 15, 2025).
How to tell if you have this one
Check for the model number REF 870021 on the kit packaging. The product was sold in the US as an IVD (in vitro diagnostic) kit with GTIN 04053228002048.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
Recall number
Product, codes & lots
Quantity
Z-0951-2022
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD); All lot numbers. GTIN number: 04053228002048
435 kits
Z-0952-2022
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA); All lot numbers
8 Kits
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the model number REF 870021 on the kit packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 17 states.
Listed by the agency
Not listed
FDA distribution: “AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Minnesota, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, West Virginia.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0951-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0951-2022 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.