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Recall Observatory FDA recall evidence

Device product

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)

Z-2665-2023

August 22, 2023

Class II

Product summary

Firm
Qiagen GmbH
Event
Event 92991
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2665-2023

Official wording

Reason: 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

Code information: GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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