cobas® EGFR Mutation Test v2 2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00875197005448), received between Jul 6, 2021 and Sep 30, 2026 — classified as 3 injuries, 126 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (112 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946527 ↗
• MalfunctionSep 24, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882042 ↗
• MalfunctionApr 15, 2026False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® EGFR MUTATION TEST V2 ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON THE COBAS Z 480 ANALYZER. THE INITIAL RESULT WAS EXON20 INSERTION MUTATION DETECTED. THE REPEAT RESULT WAS NO MUTATION DETECTED. THE SAMPLE WAS TESTED USING THE NEXT GENERATION SEQUENCING (NGS) AND THE RESULT WAS NEGATIVE FOR EXON20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888204 ↗
• MalfunctionApr 1, 2026False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE COBAS® EGFR MUTATION TEST V2 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS Z480 ANALYZER. (B)(6) 2026: EGFR EXON20INS - MUTATION DETECTED (B)(6) 2026: EGFR EXON20INS - MUTATION DETECTED (B)(6) 2026: EGFR EXON20INS - MUTATION DETECTED THE SAMPLE WAS REPEATED ON TWO OTHER METHODS, AMOY AND IDYLLA, AND NO MUTATION WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753436 ↗
• MalfunctionJan 9, 2026Adverse Event Without Identified Device or Use Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® EGFR MUTATION TEST V2 ASSAY RESULTS FOR 7 PATIENT SAMPLES TESTED ON A COBAS Z 480 ANALYZER. DATE: (B)(6) 2025 SAMPLE 1: INITIAL RESULT: MUTATION DETECTED EX19DEL REPEAT RESULT: NO MUTATION DETECTED. DATE: (B)(6) 2025 SAMPLE 2: INITIAL RESULT: MUTATION DETECTED EX19DEL REPEAT RESULT: NO MUTATION DETECTED. DATE: (B)(6) 2025 SAMPLE 3: INITIAL RESULT: MUTATION DETECTED EX19DEL REPEAT RESULT: MUTATION DETECTED; EX19DEL, T790M. DATE: (B)(6) 2025 SAMPLE 4: INITIAL RESULT: MUTATION DETECTED EX19DEL REPEAT RESULT: NO MUTATION DETECTED. SAMPLE 5: INITIAL RESULT: MUTATION DETECTED EX19DEL REPEAT RESULT: NO MUTATION DETECTED. DATE: (B)(6) 2025 SAMPLE 6: INITIAL RESULT: MUTATION DETECTED EX19DEL, T790M REPEAT RESULT: MUTATION DETECTED; EX19DEL. DATE: (B)(6) 2025 SAMPLE 7: INITIAL RESULT: MUTATION DETECTED; EX19DEL, T790M REPEAT RESULT: MUTATION DETECTED; EX19DEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022098 ↗
• MalfunctionJan 5, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR ONE PATIENT WHEN TESTED WITH THE COBAS® EGFR MUTATION TEST V2. ON (B)(6) 2025, THE INITIAL RESULT WAS NO MUTATION DETECTED. THE PATIENT UNDERWENT BOTH LIQUID BIOPSY AND TISSUE NGS TESTING, AND EGFR L858R WAS DETECTED IN BOTH SPECIMENS, WITH A MUTANT ALLELE FREQUENCY (MAF) OF APPROXIMATELY 12.5%. ON (B)(6) 2025, THE SAMPLE WAS REPEATED AND THE RESULT WAS L858R MUTATION DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958770 ↗
• MalfunctionOct 24, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2 ASSAY WITH FOUR PATIENT SAMPLES TESTED ON A COBAS Z480 ANALYZER. SAMPLE 1: ON (B)(6) 2025: THE INITIAL RESULT WAS NO MUTATION DETECTED. THE SAMPLE WAS REPEATED ON ANOTHER METHOD (OPEN QPCR INSTRUMENT USING TEST-GEN KITS (LOCALLY PRODUCED KIT)) AND THE RESULT WAS POSITIVE FOR THE L858R MUTATION. THE SAMPLE WAS SENT FOR RETESTING TO ANOTHER LABORATORY (METHOD UNKNOWN), WHERE THE MUTATION WAS CONFIRMED. SAMPLE 2: ON (B)(6) 2025: THE INITIAL RESULT WAS NO MUTATION DETECTED. THE SAMPLE WAS REPEATED ON A LOCAL TEST AND L858R MUTATION WAS DETECTED. SAMPLE 3: ON (B)(6) 2025: THE INITIAL RESULT WAS L858R MUTATION DETECTED. THE SAMPLE WAS REPEATED ON A LOCAL TEST AND L858R AND T790M MUTATIONS WERE DETECTED. SAMPLE 4: ON (B)(6) 2025: THE INITIAL RESULT WAS EXON 19 DEL MUTATION DETECTED. THE SAMPLE WAS REPEATED ON A LOCAL TEST AND EXON 19 DEL AND T790M MUTATIONS WERE DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378936 ↗
• MalfunctionMar 27, 2025False Negative Result; Output Problem; False Negative Result; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2 ASSAY UNKNOWN NUMBER OF PATIENT SAMPLES TESTED ON COBAS Z480 ANALYZER. ON (B)(6) 2025 (PLASMA SAMPLE) RESULT WAS "NO MUTATION DETECTED". ON (B)(6) 2025 (TISSUE SAMPLE) RESULT WAS "NO MUTATION DETECTED". ON AN UNKNOWN DATE, A SEQUENCING (NGS) TEST WAS PERFORMED AND THE RESULT WAS DEL19 AND L858R DETECTED. ON AN UNKNOWN DATE, ANOTHER NON-ROCHE PCR TEST WAS PERFORMED AND THE RESULT WAS DEL19 AND L858R DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706518 ↗
• MalfunctionDec 9, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2 ASSAY FOR ONE PATIENT SAMPLE TESTED ON COBAS Z480 ANALYZER. THE INITIAL RESULT WAS NO MUTATION DETECTED. THE REPEAT RESULT WITH TWO OTHER METHODS (DROPLEX EGFR MUTATION TEST V2 AND QIAGEN TEST) WAS L858R MUTATION DETECTED. ALL 3 TESTS WERE PERFORMED WITH THE SAME TISSUE BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881871 ↗
• MalfunctionNov 8, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2 ASSAY FOR ONE PATIENT SAMPLE TESTED ON COBAS Z480 ANALYZER. ON (B)(6) 2024, THE INITIAL RESULT (PLASMA SAMPLE) WAS EXON19 DEL MUTATION DETECTED. ON AN UNKNOWN DATE, A SEQUENCING (NGS) TEST WAS PERFORMED AND THE RESULT WAS MUTATION NOT DETECTED. ON (B)(6) 2024, A NEW PLASMA EXTRACTION WAS RUN ON THE COBAS Z480 ANALYZER AND THE RESULT WAS MUTATION NOT DETECTED. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640995 ↗
• MalfunctionSep 19, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® EGFR MUTATION TEST V2. PATIENT 1 ON (B)(6) 2024, THE INITIAL RESULT WAS MUTATION NOT DETECTED. ON (B)(6) 2024, THE SAME PLASMA SAMPLE WAS REPEATED AND THE RESULT WAS EXON19 DEL MUTATION DETECTED. ON (B)(6) 2024, A SEQUENCING (NGS) TEST WAS PERFORMED WITH A TISSUE SAMPLE, AND THE RESULT WAS EXON19 DEL MUTATION DETECTED. PATIENT 2 ON (B)(6) 2024, THE INITIAL RESULT WAS MUTATION NOT DETECTED. ON (B)(6) 2024, THE SAME PLASMA SAMPLE WAS REPEATED AND THE RESULT WAS EXON19 DEL MUTATION DETECTED. ON AN UNKNOWN DATE, A SEQUENCING (NGS) TEST WAS PERFORMED WITH A TISSUE SAMPLE, AND THE RESULT WAS EXON19 DEL MUTATION DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256942 ↗
• MalfunctionDec 11, 2023False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  WE RECEIVED INFORMATION THAT A CUSTOMER OBSERVED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE INITIALLY GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAME SAMPLE WAS RETESTED ON THE SAME ASSAY AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAME SAMPLE WAS ALSO RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WAS NEGATIVE FOR THE EX20INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302561 ↗
• MalfunctionNov 29, 2023Non Reproducible Results; Non Reproducible Results

  A CUSTOMER FROM HONG KONG ALLEGED DISCREPANT RESULTS WITH 3 PATIENT SAMPLES USING THE COBAS EGFR MUTATION TEST, V2. PATIENT 1 INITIALLY GENERATED NO MUTATION DETECTED RESULT ON (B)(6) 2022. THE SAMPLE WAS SENT FOR NGS IN 2022 WHICH GENERATED L858R MUTATION DETECTED RESULT. A NEW SPECIMEN WAS COLLECTED IN (B)(6) 2023 AND TESTED ON (B)(6) 2023 USING THE COBAS EGFR V2 TEST WHICH GENERATED L858R MUTATION DETECTED RESULT. PATIENT 2 INITIALLY GENERATED NO MUTATON DETECTED ON (B)(6) 2023. THE SAMPLE WAS SENT FOR NGS WHICH GENERATED E709A;G179A MUTATION DETECTED RESULT. ON (B)(6) 2023, THE SAMPLE WAS RETESTED ON THE COBAS EGFR V2 TEST AND GENERATED G179X MUTATION DETECTED RESULT. PATIENT 3 INITIALLY GENERATED NO MUTATION DETECTED RESULT ON (B)(6) 2023. THE SAMPLE WAS REPEATED ON THE COBAS EGFR V2 TEST WHICH GENERATED L858R MUTATION DETECTED RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232238 ↗
• MalfunctionNov 21, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM GREECE ALLEGED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WAS NEGATIVE FOR THE EX20INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185433 ↗
• MalfunctionAug 29, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM BRAZIL ALLEGED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WAS NEGATIVE FOR THE EX20INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647147 ↗
• MalfunctionAug 8, 2023Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED THAT 6 PATIENT SAMPLES SHOWED MUTATION DETECTED (G719X OR L858R OR EX19DEL), AND NO MUTATION DETECTED DURING INITIAL AND REPEAT TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483340 ↗
• MalfunctionJun 5, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM SPAIN ALLEGED DISCREPANT RESULTS WITH 2 PATIENT SAMPLES USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLES INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. BOTH THE SAMPLES WERE RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WERE NEGATIVE FOR THE EXON20INS. NOTE, SAMPLE 2 WAS ALSO POSITIVE FOR EXON19DEL WITH THE COBAS® EGFR MUTATION TEST V2 AND NGS, THEREFORE, THERE WAS NO DISCREPANCY FOR EXON19DEL. THE RESULTS WERE NOT REPORTED. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066321 ↗
• MalfunctionMay 24, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM GREECE ALLEGED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WAS NEGATIVE FOR THE EX20INS. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990605 ↗
• MalfunctionMay 10, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM GREECE ALLEGED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WAS NEGATIVE FOR THE EX20INS. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900847 ↗
• MalfunctionMay 2, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM THAILAND ALLEGED DISCREPANT RESULTS WITH 2 PATIENT SAMPLES USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLES INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAMPLES WERE RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND WERE NEGATIVE FOR THE EX20INS. THE RESULTS WERE NOT REPORTED. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852163 ↗
• MalfunctionMar 30, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED KINGDOM ALLEGED DISCREPANT RESULTS WITH 3 PATIENTS SAMPLES USING THE COBAS® EGFR MUTATION TEST V2. PATIENT 1: THE SAMPLE WAS TESTED WITH THE COBAS EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. A NEW DNA EXTRACTION FROM THE ORIGINAL SAMPLE WAS RETESTED USING THE COBAS EGFR MUTATION TEST V2 AND GENEREAD PANEL. BOTH GENERATED A "MUTATION NOT DETECTED" RESULT. A SAMPLE WAS REEXTRACTED FROM THE SAME INITIAL PATHOLOGY BLOCK AND WAS TESTED ON COBAS EGFR MUTATION TEST V2 AND GENEREAD PANEL. BOTH GENERATED A "MUTATION NOT DETECTED" RESULT. PATIENT 2: THE SAMPLE WAS TESTED WITH THE COBAS EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAME ELUATE WAS RETESTED USING SANGER SEQUENCING AND GENERATED A "MUTATION NOT DETECTED" RESULT. PATIENT 3: THE SAMPLE WAS TESTED WITH THE COBAS EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAME ELUATE WAS RETESTED USING NGS (NEXT GENERATION SEQUENCING) AND GENERATED A "MUTATION NOT DETECTED" RESULT. NO HARM WAS ALLEGED. FOR PATIENT 1 THE EX20INS MUTATION DETECTED RESULT WAS REPORTED BUT THEN AMENDED. IT DID NOT RESULT IN A CHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644130 ↗
• MalfunctionMar 28, 2023Non Reproducible Results; Non Reproducible Results

  A CUSTOMER FROM INDIA ALLEGED DISCREPANT RESULTS FOR ONE PATIENT WHEN USING COBAS EGFR MUTATION TEST V2. ON (B)(6) 2022 A PLASMA SAMPLE WAS TESTED USING COBAS EGFR MUTATION TEST V2 AND GENERATED AN EX19DEL MUTATION DETECTED RESULT. ON (B)(6) 2022, A TISSUE SAMPLE FROM THE SAME PATIENT WAS TESTED USING COBAS EGFR MUTATION TEST V2 AND EX19DEL MUTATION WAS NOT DETECTED. NO HARM ALLEGED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628888 ↗
• MalfunctionMar 22, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM GREECE ALLEGED A FALSE POSITIVE RESULT WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE WAS INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAME SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (AMOYDX ESSENTIAL NGS PANEL KIT WITH ILLUMINA NEXTSEQ) ASSAY AND GENERATED A MUTATION DETECTED RESULT FOR EX20 (NM_005228.5, EXON20, C.2347_2348INSG) WHICH IS A DIFFERENT MUTATION THAN THE EXON20INS MUTATION DETECTED BY COBAS® EGFR MUTATION TEST V2. THE COBAS EGFR ASSAY RESULT WAS NOT REPORTED TO THE PATIENT AND NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589884 ↗
• MalfunctionMar 7, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM GREECE ALLEGED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE WAS INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND GENERATED A "NO MUTATION DETECTED" RESULT. THE COBAS EGFR ASSAY RESULT WAS NOT REPORTED TO THE PATIENT AND NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Solid Tumor

  MAUDE report 16494199 ↗
• MalfunctionJan 19, 2023False Positive Result; False Positive Result

  A CUSTOMER FROM SPAIN ALLEGED DISCREPANT RESULTS WITH 1 PATIENT SAMPLE USING THE COBAS® EGFR MUTATION TEST V2. THE ALLEGED SAMPLE WAS INITIALLY TESTED WITH THE COBAS® EGFR MUTATION TEST V2 AND GENERATED A "MUTATION DETECTED" RESULT FOR EXON20INS. THE SAME SAMPLE WAS RETESTED USING NEXT GENERATION SEQUENCING (NGS) AND GENERATED A "MUTATION NOT DETECTED" RESULT. THE COBAS EGFR ASSAY RESULT WAS NOT REPORTED TO THE PATIENT AND NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Solid Tumor

  MAUDE report 16210519 ↗