Elecsys CEA 07027079190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630939664), received between Aug 25, 2022 and Aug 6, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161490 ↗
• MalfunctionJan 15, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CEA ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.86 NG/ML. THE REPEAT RESULT WAS 1.25 NG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082479 ↗
• MalfunctionJan 12, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CEA RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 10.8 NG/L, AND THE REPEATED RESULTS WERE 2.85 NG/ML AND 2.90 NG/L. THE REPEATED RESULT OF 2.90 NG/L WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DIDN'T MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE PATIENT'S CLINICAL DIAGNOSIS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035754 ↗
• MalfunctionDec 21, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CEA ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CEA VALUE OF 135 NG/ML. NEW SAMPLES COLLECTED FROM THE PATIENT WERE TESTED FOR CEA AT DIFFERENT LABORATORIES ON BOTH ROCHE AND COMPETITOR SYSTEMS AND THE RESULTS WERE WITHIN EXPECTED REFERENCE RANGES. SPECIFIC RESULTS COULD NOT BE PROVIDED. THE COMPLAINED SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN A CEA VALUE OF 1.42 NG/ML. THE REPEAT VALUE WAS DEEMED CORRECT BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860433 ↗
• MalfunctionMay 9, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS CEA ASSAY ON A COBAS E801 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 855 NG/ML. SAMPLE 2: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 7.69 NG/ML. SAMPLE 3: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 2.87 NG/ML. SAMPLE 4: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 1.89 NG/ML. THE INITIAL RESULTS WERE LOWER THAN THE TECHNICAL TEST LIMIT, PROMPTING THE REPEAT OF THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996643 ↗
• MalfunctionMay 9, 2025High Readings; Low Readings; High Readings; Low Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 11 PATIENT SAMPLES TESTED WITH ELECSYS CEA ON A COBAS E 801 ANALYTICAL UNIT. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE CUSTOMER STATED THEY OBTAINED SYSTEMATICALLY LOWER RESULTS WITH ONE REAGENT PACK (PACK B) IN COMPARISON TO RESULTS FROM OTHER PACKS OF THE SAME LOT (PACKS A, C, D) AND RESULTS OBTAINED FROM A DIFFERENT LOT ON A SECOND ANALYZER (E602) AT ANOTHER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994407 ↗
• MalfunctionOct 21, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CEA (CEA) ON A COBAS E 801 MSB/MSBL. THE INITIAL RESULT WAS 11.8 NG/L. THE REPEAT RESULT WAS <0.3 NG/L. ON (B)(6) 2025 THE REPEAT RESULT WAS <0.3 NG/L. THE INITIAL RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION AND THE SAMPLE WAS REPEATED. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494941 ↗
• MalfunctionSep 26, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CEA ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 4.22 NG/ML (POSITIVE). THE REPEAT RESULT OF THE RECENTRIFUGED PATIENT SAMPLE FROM THE ANALYZER WAS 4.26 NG/ML (POSITIVE). THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY. THE REPEAT RESULT FROM A SIEMENS ANALYZER (CHEMILUMINESCENCE LABORATORY METHOD) WAS 1.58 NG/ML (NEGATIVE). THE REPEAT RESULT FROM A BECKMAN ANALYZER (UNKNOWN LABORATORY METHOD) WAS ALSO NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312291 ↗
• MalfunctionJul 12, 2024Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CEA ASSAY, ELECSYS CYFRA 21-1 ASSAY, AND ELECSYS HE4 ASSAY ON A COBAS 8000 COBAS E602 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER. THIS MEDWATCH WILL APPLY TO THE CYFRA 21-1 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CEA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE HE4 ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE E602 ANALYZER AND REPEATED ON A NON-ROCHE ANALYZER ON (B)(6) 2024. TWO TEST RESULTS WERE CONSISTENT. CEA: INITIAL RESULT: 13.62 NG/ML. REPEAT RESULT: 13.37 NG/ML. CYFRA 21-1: INITIAL RESULT: 54.37 NG/ML. REPEAT RESULT: 55.767 NG/ML. HE4: INITIAL RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 1967.4 PMOL/L. REPEAT RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 4151.754 PMOL/L. THE ABOVE PATIENT TEST RESULTS WERE CONSIDERED HIGHER THAN THE NORMAL REFERENCE RANGE. THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730395 ↗
• MalfunctionJul 12, 2024Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CEA ASSAY, ELECSYS CYFRA 21-1 ASSAY, AND ELECSYS HE4 ASSAY ON A COBAS 8000 COBAS E602 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER. THIS MEDWATCH WILL APPLY TO THE CEA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CYFRA 21-1 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE HE4 ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE E602 ANALYZER AND REPEATED ON A NON-ROCHE ANALYZER ON (B)(6) 2024. TWO TEST RESULTS WERE CONSISTENT. CEA: INITIAL RESULT: 13.62 NG/ML. REPEAT RESULT: 13.37 NG/ML. CYFRA 21-1: INITIAL RESULT: 54.37 NG/ML. REPEAT RESULT: 55.767 NG/ML. HE4: INITIAL RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 1967.4 PMOL/L. REPEAT RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 4151.754 PMOL/L. THE ABOVE PATIENT TEST RESULTS WERE CONSIDERED HIGHER THAN THE NORMAL REFERENCE RANGE. THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730337 ↗
• MalfunctionJul 12, 2024Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CEA ASSAY, ELECSYS CYFRA 21-1 ASSAY, AND ELECSYS HE4 ASSAY ON A COBAS 8000 COBAS E602 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER. THIS MEDWATCH WILL APPLY TO THE HE4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CEA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CYFRA 21-1 ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE E602 ANALYZER AND REPEATED ON A NON-ROCHE ANALYZER ON (B)(6) 2024. TWO TEST RESULTS WERE CONSISTENT. CEA: INITIAL RESULT: 13.62 NG/ML. REPEAT RESULT: 13.37 NG/ML. CYFRA 21-1: INITIAL RESULT: 54.37 NG/ML. REPEAT RESULT: 55.767 NG/ML. HE4: INITIAL RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 1967.4 PMOL/L. REPEAT RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 4151.754 PMOL/L. THE ABOVE PATIENT TEST RESULTS WERE CONSIDERED HIGHER THAN THE NORMAL REFERENCE RANGE. THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730333 ↗
• MalfunctionOct 28, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CEA ELECSYS E2G RESULTS FROM THE COBAS E 801 MODULE. SAMPLE 1 INITIAL RESULT WAS 23.3 NG/ML. THE REPEAT RESULTS WERE 1.42 NG/ML AND 1.42 NG/ML. ON (B)(6) 2022, SAMPLE 2 INITIAL RESULT WAS 64.0 NG/ML. THE REPEAT RESULTS WERE 3.15 NG/ML AND 3.17 NG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER WAS 607340 WITH AN EXPIRATION DATE OF 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690069 ↗
• MalfunctionAug 25, 2022High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FROM 2 SAMPLES FROM 1 PATIENT NOT CORRESPONDING TO THE CLINICAL PICTURE WHEN TESTED FOR ELECSYS CEA (CEA) ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 RESULT FROM THE E801 UNIT WAS 19.8 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 5 NG/ML). THE SAMPLE WAS REPEATED ON THE SAME UNIT WITH A RESULT OF 20.7 NG/ML. THE SAMPLE WAS REPEATED ON A DIFFERENT E801 MODULE WITH A RESULT OF 20 NG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 3.53 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 10 NG/ML). ON 28-JUL-2022 SAMPLE 2 RESULT FROM THE E801 UNIT WAS 20.3 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 5 NG/ML). THE SAMPLE WAS REPEATED ON A DIFFERENT E801 MODULE WITH A RESULT OF 20.8 NG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 3.75 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 10 NG/ML). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT HAD BEEN TREATED AFTER RADICAL RESECTION OF ESOPHAGEAL SQUAMOUS CELL CARCINOMA WITH ALBUMIN PACLITAXEL AND SINTILIMAB FOR 4 CYCLES OF TREATMENT THEN SINTILIMAB FOR 16 CYCLES OF TREATMENT. BASED ON THE TREATMENT RECEIVED, THE DOCTOR THOUGHT THE CEA RESULTS SHOULD BE WITHIN THE NORMAL RANGE. THE E801 UNIT SERIAL NUMBER WAS (B)(4). THE SERIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293886 ↗