Somatic Gene Mutation Detection System

Reports per year

Source: FDA adverse event reports by year received, 2014–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-09-29Open, ClassifiedUnder Investigation by firm

  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)

  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

• 2015-06-26TerminatedDevice Design

  cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.

  cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.

• 2015-03-25TerminatedUnder Investigation by firm

  cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

  False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.

• 2012-11-02TerminatedMixed-up of materials/components

  cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).

  It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control

• Open, ClassifiedUnder Investigation by firm

  cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

  False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

• TerminatedProcess control

  therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

  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.

• Open, ClassifiedDevice Design

  therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

  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.

• Open, ClassifiedDevice Design

  therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

  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.

• Open, ClassifiedUnder Investigation by firm

  therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721

  Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects

• Open, ClassifiedUnder Investigation by firm

  therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

  Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects