Reported Oct 11, 2023 · Ongoing
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection…
Qiagen GmbH
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 GmbH · Qiagen Str. 1 · Hilden, N/A · N/A
Is this the product you have?
- therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
- Lot codes and dates
- GTIN number04053228002048 All lots that have an expiry date of March 2023 or later
- Amount recalled
- N/A
Where it was sold
Why it was recalled
Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid
This product could cause temporary or reversible health problems — stop using it.
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