Reported Apr 27, 2022 · Ongoing
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Qiagen Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
- therascreen
- KRAS RGQ PCR Kit (24) Model Number(s)REF 870021 (US IVD)
- Lot codes and dates
- All lot numbers
- GTIN number04053228002048
- Amount recalled
- 435 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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