cobas e 602 Immunoassay Analyzer 05990378001Recalls & reported problems

Summary

The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 04015630929764), received between Jul 11, 2018 and Sep 29, 2026 — classified as 297 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (190 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 297 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Low Test Results

  We received an allegation about discrepant results for 2 patients' samples tested with Elecsys Troponin T Gen 5 STAT assay and 1 patient sample tested with Elecsys Ferritin - 200 Kit assay on a cobas e 602 module.Patient (b)(6): Troponin T:Initial result: 9.97 ng/L.Repeat result: 58.69 ng/L (tested on a different e 602 module).Patient (b)(6): Troponin T:Initial result: <6 ng/L.Repeat result: 14.68 ng/L (tested on a different e 602 module).Patient (b)(6): Ferritin:Initial result: 6.54 ng/mL.Repeat result: 25.1 ng/mL.The Emergency Room physician questioned the initial results, prompting a repeat of the samples for Patient 1, Patient 2, and Patient 3 on (b)(6)2026.The repeat results were deemed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931496 ↗
• MalfunctionSep 8, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675848 ↗
• MalfunctionJun 10, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT4 IV RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. THE INITIAL ELECSYS FT3 III RESULT WAS 5.89 PG/ML. THE REPEAT RESULT ON ANOTHER UNIT WAS 1.80 PG/ML. THE INITIAL ELECSYS FT4 IV RESULT WAS 3.10 NG/DL. THE REPEAT RESULT ON ANOTHER UNIT WAS 1.60 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456474 ↗
• MalfunctionMay 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III AND ELECSYS TSH ASSAY RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS 8000 E 602 MODULE. PLEASE REFER TO THE ATTACHMENT PT-(B)(6) FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285845 ↗
• MalfunctionMay 8, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. THE CUSTOMER WAS PERFORMING INSTRUMENT COMPARISON STUDIES WHICH CAUSED THEM TO QUESTION THE INITIAL RESULT. ON (B)(6) 2026, THE INITIAL RESULT WAS 72 PG/ML. ON (B)(6) 2026, THE SAMPLE WAS REPEATED TWICE ON ANOTHER ANALYZER AND THE RESULTS WERE 7030 PG/ML AND 6718 PG/ML. THE SAMPLE WAS REPEATED AGAIN ON THE ORIGINAL ANALYZER AND THE RESULT WAS 7011 PG/ML. THE RESULT OF 7011 PG/ML WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124618 ↗
• MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR 19 PATIENT SAMPLES ON A COBAS 8000 - COBAS E 602 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000458 ↗
• MalfunctionMar 30, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS E 602 MODULE. THE FOLLOWING EXAMPLE RESULTS FOR ONE PATIENT SAMPLE WERE PROVIDED: THE INITIAL RESULT WAS 8.25 PG/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 2.53 PG/ML AND 2.5 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714615 ↗
• MalfunctionMar 13, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS AFP ASSAY RESULT FOR THREE PATIENT SAMPLES TESTED ON A COBAS E 602 MODULE.' SAMPLE 1: THE INITIAL RESULT WAS 38.23NG/ML. THE REPEAT RESULT WAS 3.25NG/ML. SAMPLE 2: THE INITIAL RESULT WAS 37.01NG/ML. THE REPEAT RESULT WAS 2.5NG/ML. SAMPLE 3: THE INITIAL RESULT WAS 148 NG/ML. THE REPEAT RESULT WAS 2.29NG/ML. THE TEST WAS REPEATED AS THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSIS. THE REPEAT RESULTS WERE DEEMED CORRECT. NO ERRONEOUS RESULTS WERE RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598268 ↗
• MalfunctionFeb 26, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CEA RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 602 MODULE. THE INITIAL RESULT WAS 5.22 NG/ML. THE REPEAT RESULT WAS 1.07 NG/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458025 ↗
• MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HIV COMBI PT ASSAY ON A COBAS E 602 MODULE. THE SAMPLE WAS INITIALLY TESTED 3 TIMES, AND THE RESULTS WERE 6.27 COI, 6.30 COI, AND 6.51 COI, WHICH WERE INTERPRETED AS "REACTIVE". ON (B)(6) 2026, THE RESULT OF AN ALIQUOT OF THE PATIENT SAMPLE FROM A DIFFERENT FACILITY WAS "NON-REACTIVE". THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AS ALL REACTIVE RESULTS ARE SENT OUT FOR CONFIRMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413867 ↗
• MalfunctionFeb 13, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA RESULTS FOR 1 PATIENT ON A COBAS E 602 MODULE. THE INITIAL RESULT WAS 0.326 MIU/ML. THE REPEATED RESULT WAS 3518 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333409 ↗
• MalfunctionJan 27, 2026False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HSV-2 IGG RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 1.70 COI (REACTIVE). THE CUSTOMER HAD A POLICY TO REPEAT REACTIVE RESULTS, SO THE SAMPLE WAS REPEATED IN DUPLICATE. THE REPEAT RESULTS WERE NON-REACTIVE AND WERE BELIEVED TO BE CORRECT. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED AT A DIFFERENT LABORATORY, AND THE RESULT WAS NON-REACTIVE/NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188035 ↗
• MalfunctionJan 26, 2026High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 8000 - COBAS E 602 MODULE. 2. PATIENT AGE RANGE: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183975 ↗
• MalfunctionDec 10, 2025High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF ANALYZER ALARMS AND QUESTIONABLE RESULTS FOR PATIENT SAMPLES AND QC MATERIAL FROM THE COBAS 8000 - COBAS E 602 MODULE. THE SAMPLES WERE REPEATED ON ANOTHER MODULE. SAMPLE 1 INITIAL TOTAL PSA RESULT WAS 2.51, AND THE REPEAT RESULT WAS 7.85. SAMPLE 2 INITIAL CORTISOL RESULT WAS 54.6, AND THE REPEAT RESULT WAS 12.97. SAMPLE 3 INITIAL CORTISOL RESULT WAS 52.53, AND THE REPEAT RESULT WAS 15.72. SAMPLE 4 INITIAL TOTAL PSA RESULT WAS 1.65, AND THE REPEAT RESULT WAS 4.18. THE UNITS OF MEASURE WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766976 ↗
• MalfunctionNov 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TROPONIN T HS STAT ASSAY ON THE COBAS E 602 MODULE. FOUR DIFFERENT BLOOD DRAWS FROM THE SAME PATIENT WERE TESTED. SAMPLE 1 WAS TESTED AT 8:00 PM: 9 NG/L. SAMPLE 2 WAS TESTED AT 11:00 PM: 32 NG/L. ON (B)(6) 2025: SAMPLE 3 WAS TESTED AT 2 AM: 12 NG/L. SAMPLE 4 WAS TESTED AT 8 AM: 12 NG/L. SAMPLE 2'S RESULTS WERE QUESTIONED, PROMPTING THE RERUN. THE REPEAT RESULTS ARE: 32 NG/L, 28 NG/L, AND 14 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632034 ↗
• MalfunctionNov 21, 2025Device Sensing Problem; Non Reproducible Results; Device Sensing Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG+BETA RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 602 MODULE. THE INITIAL RESULT WAS 0.394 MIU/ML. THE REPEAT RESULT WAS 4673 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619586 ↗
• MalfunctionNov 14, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 0.01IU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 116 IU/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555031 ↗
• MalfunctionNov 10, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FT3 III RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 602 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 22.57 PG/ML. THE REPEAT RESULT FROM THE MODULE WAS 2.45 PG/ML. THE REPEAT RESULT FROM ANOTHER MODULE WAS 2.61 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512175 ↗
• MalfunctionNov 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS CA 19-9 ASSAY AND 2 PATIENTS' SAMPLES TESTED WITH ELECSYS FERRITIN ASSAY ON A COBAS 8000 - COBAS E 602 MODULE. SAMPLE 1 AND SAMPLE 2 WERE TESTED FOR CA19-9: SAMPLE 1: INITIAL RESULT: 198.4 U/ML. REPEAT RESULT: <0.600 U/ML (<MEASURING RANGE OF 0.600-1000 U/ML). SAMPLE 2: INITIAL RESULT: 4400 U/ML. REPEAT RESULT: 51 U/ML. SAMPLE 3 AND SAMPLE 4 WERE TESTED FOR FERRITIN: SAMPLE 3: INITIAL RESULT: <0.50 NG/ML (<MEASURING RANGE OF 0.50-2000 NG/ML). REPEAT RESULT: 34 NG/ML. SAMPLE 4: INITIAL RESULT: 0.800 NG/ML. REPEAT RESULT: 434 NG/ML, AND THIS RESULT WAS DEEMED TO BE CORRECT. THE CUSTOMER REPEATED THE SAMPLES DUE TO PROFICIENCY TESTING FAILURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476872 ↗
• MalfunctionNov 4, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 8216 PMOL/L. THE REPEAT RESULT WAS 80 PMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462377 ↗
• MalfunctionNov 3, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BETA HCG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 28389 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450031 ↗
• MalfunctionOct 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Suction Problem; Incorrect, Inadequate or Imprecise Result or Readings; Suction Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TROPONIN T RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 602 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 121 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 58 NG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. SAMPLE 2: THE INITIAL RESULT WAS <3 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 12 NG/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437096 ↗
• MalfunctionOct 24, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. THE CUSTOMER REPORTED THAT THE SAMPLE INITIALLY TESTED HIGHLY POSITIVE AND WHEN REPEATED, THE RESULT WAS NEGATIVE. REPEAT MEASUREMENT ON 2 DIFFERENT ANALYZERS CONFIRMED THE NEGATIVE RESULT. THE SPECIFIC RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381893 ↗
• MalfunctionOct 20, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HCG RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. PATIENT 1 INITIAL RESULT WAS "30+" MIU/ML. PATIENT 2 INITIAL RESULT WAS "40+" MIU/ML. THE SAMPLES WERE REPEATED USING A COBAS 411 ANALYZER. PATIENT 1 REPEAT RESULT WAS "20000+" MIU/ML. PATIENT 2 REPEAT RESULT WAS "30000+" MIU/ML. THE SAMPLES WERE THEN REPEATED USING THE COBAS 602 ANALYZER, AND THE RESULTS WERE COMPARABLE TO THE RESULTS FROM THE COBAS E411. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334968 ↗
• MalfunctionSep 18, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HBSAG II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 602 MODULE. THE INITIAL RESULT FROM THE ANALYZER WAS 0.33 CUT-OFF INDEX COI (NON-REACTIVE). THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 1.09 COI (REACTIVE). THE SECOND REPEAT RESULT FROM ANOTHER E602 ANALYZER RESULT WAS 0.33 COI (NON-REACTIVE). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081731 ↗