cobas e 402 analytical unit 09793020001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613336220139), received between Sep 18, 2024 and Apr 23, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Intermittent Program or Algorithm Execution

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PSA ELECSYS E2G RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.0140 NG/ML WITH FLAG. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER NOTICED AN ADDITIONAL PIPETTING TIME 30 SECONDS AFTER THE INITIAL TEST OF THE SAME SAMPLE WITH A RESULT OF 4.4 NG/ML. THE CUSTOMER HAD NOT REQUESTED A REPEAT OF THE SAMPLE AND AUTO-REPEATS FOR THE ASSAY WERE NOT CONFIGURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969137 ↗
• MalfunctionMar 11, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. ONLY DATA FOR ONE SAMPLE FOR VITAMIN B12 WAS PROVIDED. THE INITIAL RESULT WAS 1149 PG/ML, AND THE REPEAT RESULT WAS 555 PG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575809 ↗
• MalfunctionNov 6, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 402 ANALYTICAL UNIT. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS T4. ELECSYS T-UPTAKE, ELECSYS TSH. THE SAMPLE WAS REPEATED DUE TO DATA FLAGS ON THE INITIAL VALUES FOR T-UPTAKE AND T4. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: T-UPTAKE = < 57.0 TBI WITH A DATA FLAG T4 = > 24.9 UG/DL WITH A DATA FLAG TSH = 0.316 UIU/ML. THE SAMPLE WAS REPEATED ON AN UNKNOWN DEVICE, RESULTING IN THE FOLLOWING VALUES: T-UPTAKE = 25 TBI WITH A DATA FLAG T4 = 7.5 UG/DL WITH A DATA FLAG TSH = 1.530 UIU/ML. THE REPEAT VALUES WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488032 ↗
• MalfunctionJun 9, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T GEN5 ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 0.06 NG/L (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 36 NG/L. SAMPLE 2: INITIAL RESULT: 8.52 NG/L. REPEAT RESULT: 13.8 NG/L. THE EMERGENCY ROOM QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' PREVIOUS RESULTS AND REQUESTED THE SAMPLES TO BE REPEATED. THE SAMPLES WERE THEN REPEATED AT A DIFFERENT LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165884 ↗
• MalfunctionApr 18, 2025Mechanical Problem; High Test Results; Non Reproducible Results; Mechanical Problem; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T GEN 5 ON A COBAS PURE E 402 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 174 NG/L. THE DOCTOR QUESTIONED THE RESULT BECAUSE THE PATIENT HAS HISTORICALLY HAD TROPONIN T RESULTS IN THE "30S" NG/L. THE SAMPLE WAS REPEATED, RESULTING IN A TROPONIN T VALUE OF 32.7 NG/L. THIS VALUE WAS DEEMED CORRECT. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A TROPONIN T VALUE OF 30.6 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867465 ↗
• MalfunctionSep 18, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROCALCITONIN V2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON TWO COBAS PURE E 402 ANALYTICAL UNIT - EMC (COBAS A AND COBAS B). THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM COBAS A WAS >100 NG/ML WITH A DATA FLAG. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM COBAS B WAS >100 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:4 MANUAL DILUTION FROM COBAS A WAS 14.1 NG/ML WITH A FINAL CALCULATED DILUTION RESULT OF 56.4 NG/ML. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:4 MANUAL DILUTION FROM COBAS B WAS 14.0 NG/ML WITH A FINAL CALCULATED DILUTION RESULT OF 56 NG/ML. THE REPORTER PERFORMED AN ADDITIONAL RERUN AND SENT THE PATIENT TO ANOTHER LABORATORY FOR INVESTIGATION: THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:4 MANUAL DILUTION FROM COBAS A WAS 23.9 NG/ML WITH A FINAL CALCULATED DILUTION RESULT OF 95.6 NG/ML. THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:4 MANUAL DILUTION FROM ANOTHER LABORATORY WAS 23.2 NG/ML WITH A FINAL CALCULATED DILUTION RESULT OF 92.8 NG/ML. THIS RESULT WAS DEEMED CORRECT AND REPORTED. THE REPORTER STATED THAT THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250547 ↗