cobas e 801 Immunoassay analyzerRecalls & reported problems across all models

We found 3 models of cobas e 801 Immunoassay analyzer by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 713 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Sep 30, 2026 — classified as 3 injuries, 710 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (509 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

cobas e 801 Immunoassay analyzer recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 14, 2022Open, Classified

   Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

   Z-1515-2022 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported cobas e 801 Immunoassay analyzer problems

cobas e 801 Immunoassay analyzer models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• cobas e 801 Immunoassay Analyzer 07682913001

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall417 reports
• cobas e 801 Immunoassay analyzer 08454345001

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall295 reports
• cobas e 801 Immunoassay analyzer 08459606001

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 report

Recent cobas e 801 Immunoassay analyzer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results

  The initial reporter received a questionable Elecsys total PSA assay result for one patient sample tested on the cobas e 801 analytical unit.On 03-Sep-2026:Initial analysis yielded 21.3 ng/mL.On 07-Sep-2026:Repeat analysis yielded 7.26 ng/mL.Repeat analysis using a different sample tube yielded 6.94 and 7.11 ng/mL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946530 ↗
• MalfunctionSep 11, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736895 ↗
• MalfunctionAug 14, 2026Low Test Results; Decreased Sensitivity; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260188 ↗
• MalfunctionJun 10, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TPO ASSAY ON A COBAS 8000 E 801 MODULE. INITIAL RESULT: 95 IU/ML. 1ST REPEAT RESULT: <9 IU/ML. 2ND REPEAT RESULT: 17 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460393 ↗
• MalfunctionMay 27, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PTH RESULTS FOR THREE PATIENT SAMPLES FROM THE COBAS E 801 MODULE. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 10 PG/ML, AND THE REPEAT RESULT WAS ABOUT 100 PG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AS IT AGREED WITH THE PREVIOUS RESULT FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305777 ↗
• MalfunctionMay 6, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH AND ELECSYS FT4 IV RESULTS FROM THE COBAS 8000 E 801 MODULE FOR ONE PATIENT. THE INITIAL TSH RESULT WAS 32.3 IU/ML. THE REPEAT RESULT ON ANOTHER E801 INSTRUMENT WAS 61.0 ¿IU/ML. THE REPEAT RESULT ON ANOTHER E801 INSTRUMENT WAS 63.5 ¿IU/ML. THE INITIAL FT4 RESULT WAS 6.7 PMOL/L. THE REPEAT RESULT ON ANOTHER E801 INSTRUMENT WAS 3.38 PMOL/L. THE REPEAT RESULT ON ANOTHER E801 INSTRUMENT WAS 3.29 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100139 ↗
• MalfunctionMay 6, 2026Leak/Splash

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS 8000 E 801 MODULE. THE CUSTOMER PROVIDED EXAMPLES OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS INSULIN, ELECSYS PTH, AND ELECSYS IGE II. THE CUSTOMER STATED THAT THEIR MOVING AVERAGE INDICATED AN ISSUE AND WAS ALSO HAVING QC ISSUES, WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES. SAMPLE 1 HAD AN INITIAL PTH RESULT OF 8.26 PG/ML. THE REPEAT RESULT WAS 102 PG/ML. SAMPLE 2 HAD AN INITIAL PTH RESULT OF 11.8 PG/ML. THE REPEAT RESULT WAS 106 PG/ML. SAMPLE 3 HAD AN INITIAL IGE RESULT OF 182 IU/ML. THE REPEAT RESULT WAS 3510 IU/ML. SAMPLE 4 HAD AN INITIAL INSULIN RESULT OF 0.7 UIU/ML. THE REPEAT RESULT WAS 7.33 UIU/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25098816 ↗
• MalfunctionApr 23, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HBC ASSAY RESULTS FOR PATIENT SAMPLES TESTED ON A COBAS 8000 E 801 MODULE. SAMPLE 1 THE INITIAL RESULT WAS 0.000948 COI (REACTIVE). THE REPEAT RESULTS WERE 0.000899 COI (REACTIVE), 0.000893 COI (REACTIVE), AND 2.21 (NON-REACTIVE). SAMPLE 2: THE INITIAL RESULT WAS 0.000937 COI (REACTIVE). THE REPEAT RESULTS WERE 0.0307 COI (REACTIVE), 0.00107 COI (REACTIVE), AND 2.18 (NON-REACTIVE). SAMPLE 3: THE INITIAL RESULT WAS 0.000980 COI (REACTIVE). THE REPEAT RESULTS WERE 0.188 COI (REACTIVE), 2.14 COI (NON-REACTIVE), AND 2.14 (NON-REACTIVE). SAMPLE 4: THE INITIAL RESULT WAS 0.00183 COI (REACTIVE). THE REPEAT RESULTS WERE 0.000923 COI (REACTIVE), 1.54 COI (NON-REACTIVE), AND 1.54 (NON-REACTIVE). SAMPLE 5: THE INITIAL RESULT WAS 0.00102 COI (REACTIVE). THE REPEAT RESULTS WERE 0.00185 COI (REACTIVE), 2.13 COI (NON-REACTIVE), AND 2.25 (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969775 ↗
• MalfunctionApr 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II RESULTS FROM THE COBAS 8000 E 801 MODULE FOR APPROXIMATELY 17 PATIENTS. HERE ARE 4 REPRESENTATIVE EXAMPLES. PATIENT 1'S INITIAL RESULT WAS 1.12 COI (REACTIVE). THE FIRST REPEAT RESULT WAS 0.495 COI (NON-REACTIVE). THE SECOND REPEAT RESULT WAS 0.463 COI (NON-REACTIVE). PATIENT 2'S INITIAL RESULT WAS 3.55 COI (REACTIVE). THE FIRST REPEAT RESULT WAS 0.314 COI (NON-REACTIVE). THE SECOND REPEAT RESULT WAS 0.368 COI (NON-REACTIVE). PATIENT 3'S INITIAL RESULT WAS 3.47 COI (REACTIVE). THE FIRST REPEAT RESULT WAS 0.512 COI (NON-REACTIVE). THE SECOND REPEAT RESULT WAS 0.480 COI (NON-REACTIVE). PATIENT 4'S INITIAL RESULT WAS 0.44 COI (NON-REACTIVE). THE FIRST REPEAT RESULT WAS 7.97 COI (REACTIVE). THE SAMPLE WAS SENT TO ANOTHER LABORATORY, AND THE RESULT WAS NON-REACTIVE. THE EXACT RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886104 ↗
• MalfunctionApr 8, 2026Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FOLATE III ON A COBAS E 801 MODULE. THE SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF 6 NG/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZE ON (B)(6) 2026, RESULTING IN A VALUE OF 4 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816643 ↗
• MalfunctionApr 1, 2026False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE VITAMIN D ASSAY RESULT. THE INITIAL RESULT WAS 45.6 NG/ML. THE REPEAT RESULT WAS 9.96 NG/ML. NO ERRONEOUS RESULT WAS RELEASED OUTSIDE THE LAB. THE TEST WAS REPEATED AS THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757240 ↗
• MalfunctionMar 17, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 62 PATIENT SAMPLES TESTED FOR ELECSYS TSH V2 (TSH), ELECSYS FT4 IV (FT4 IV), ELECSYS IGE II (IGE II), ELECSYS FT3 III (FT3 III) AND ELECSYS T3 (T3) ON A COBAS 8000 E 801 MODULE. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 5 PATIENT SAMPLES. PATIENT 1 INITIAL IGE II RESULT WAS 0.200 IU/ML. THE REPEAT RESULT WAS 337 IU/ML. PATIENT 2 INITIAL T3 RESULT WAS 0.553 NG/ML. THE REPEAT RESULT WAS 0.986 NG/ML. PATIENT 3 INITIAL TSH RESULT WAS 0.0734 UIU/ML. THE REPEAT RESULT WAS 1.38 UIU/ML. PATIENT 4 INITIAL FT3 III RESULT WAS 0.6 PMOL/L. THE REPEAT RESULT WAS 4.54 PMOL/L. PATIENT 5 INITIAL FT4 IV RESULT WAS 0.259 NG/DL. THE REPEAT RESULT WAS 1.64 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621932 ↗
• MalfunctionMar 17, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TROPONIN T HS ASSAY RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS 8000 E 801 MODULE. SAMPLE 1: THE TNT RESULT WAS 17.6 PG/ML. THE SAMPLE WAS RESPUN AND REPEATED, GIVING A RESULT OF <5 PG/ML FOR TNT. THE TNTST RESULT WAS <5 PG/ML. SAMPLE 2: THE TNT INITIAL RESULT WAS 12.9 PG/ML. THE TNT REPEAT RESULT WAS 3.42 PG/ML. THE TNTST INITIAL RESULT WAS 4.08 PG/ML. THE TNTST REPEAT RESULT WAS <3 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619909 ↗
• MalfunctionMar 2, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS PROBNP II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 33.2 PG/ML. THE REPEAT RESULT WAS 4831 PG/ML. THE PATIENT SAMPLE WAS RERUN DUE TO THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488223 ↗
• MalfunctionFeb 26, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN T ON A COBAS 8000 E 801 MODULE. THE CUSTOMER NOTED THEY WERE ALSO RECEIVING SAMPLE CLOT DETECTION ERRORS. THE COMPLAINED SAMPLE, COLLECTED AT 13:41, INITIALLY RESULTED IN A TROPONIN T VALUE OF 32.6 NG/L. A SECOND SAMPLE COLLECTED FROM THE PATIENT AT 17:52 RESULTED IN A TROPONIN T VALUE OF 3 NG/L. A THIRD SAMPLE COLLECTED FROM THE PATIENT AT 23:36 RESULTED IN A TROPONIN T VALUE OF < 3 NG/L. THE COMPLAINED SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A TROPONIN T VALUE OF 6.4 NG/L. THIS VALUE WAS MORE IN LINE WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455684 ↗

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