cobas e 801 Immunoassay Analyzer 07682913001Recalls & reported problems

Summary

The FDA's MAUDE database contains 417 adverse event reports that list this exact device (DI 04015630946198), received between Jul 13, 2018 and Sep 30, 2026 — classified as 2 injuries, 415 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (290 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K162606); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jul 14, 2022Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 417 reports, 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 ↗
• MalfunctionFeb 18, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E 801 MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 11 PATIENT SAMPLES TESTED. THE CUSTOMER COMPLAINED THAT THEY HAVE HAD AN INCREASE IN POSITIVE AND BORDERLINE RESULTS THAT ARE NEGATIVE UPON REPEAT ON ANOTHER MODULE. SAMPLE 1 HAD AN INITIAL RESULT OF 1.05 COI. THE REPEAT RESULT WAS 0.704 COI. SAMPLE 2 HAD AN INITIAL RESULT OF 1.03 COI. THE REPEAT RESULT WAS 0.463 COI. SAMPLE 3 HAD AN INITIAL RESULT OF 1.28 COI. THE REPEAT RESULT WAS 0.496 COI. SAMPLE 4 HAD AN INITIAL RESULT OF 1.1 COI. THE REPEAT RESULT WAS 0.438 COI. SAMPLE 5 HAD AN INITIAL RESULT OF 1.26 COI. THE REPEAT RESULT WAS 0.461 COI. SAMPLE 6 HAD AN INITIAL RESULT OF 1.43 COI. THE REPEAT RESULT WAS 0.626 COI. SAMPLE 7 HAD AN INITIAL RESULT OF 1.61 COI. THE REPEAT RESULT WAS 0.621 COI. SAMPLE 8 HAD AN INITIAL RESULT OF 1.47 COI. THE REPEAT RESULT WAS 0.379 COI. SAMPLE 9 HAD AN INITIAL RESULT OF 1.13 COI. THE REPEAT RESULT WAS 0.594 COI. SAMPLE 10 HAD AN INITIAL RESULT OF 1.06 COI. THE REPEAT RESULT WAS 0.44 COI. SAMPLE 11 HAD AN INITIAL RESULT OF 1.06 COI. THE REPEAT RESULT WAS 0.651 COI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379879 ↗
• MalfunctionFeb 10, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN D TOTAL II (VITAMIN D II) ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 107 NG/ML. THE REPEAT RESULT WAS 46 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306011 ↗
• MalfunctionFeb 4, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULT FROM THE COBAS 8000 E 801 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 58 NG/L. A REPEAT RESULT ON ANOTHER ANALYZER WAS LESS THAN OR EQUAL TO 6.0 NG/L. A REPEAT RESULT ON ANOTHER ANALYZER WAS 7.79 NG/L. THE RESULT OF LESS THAN OR EQUAL TO 6.0 NG/L WAS DEEMED TO BE CORRECT. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE IT DID NOT MATCH THE CLINICAL PICTURE AS WELL AS THE RESULT FROM A PREVIOUS SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257149 ↗
• MalfunctionFeb 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR APPROXIMATELY 20-30 PATIENT SAMPLES ON A COBAS 8000 E 801 MODULE. ONLY 1 EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 18.1 UG/DL. THE REPEATED RESULT WAS 35.4 UG/DL. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED BECAUSE QC FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248635 ↗
• MalfunctionJan 20, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T HS RESULT FROM THE COBAS 8000 E 801 MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 68.0 NG/L, AND THE REPEAT RESULT WAS 3.0 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116951 ↗
• MalfunctionJan 15, 2026Incorrect Measurement; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MODULE. THE INITIAL RESULT FROM THE MODULE WAS <150 PG/ML. THE REPEAT RESULT FROM ANOTHER MODULE WAS 906 PG/ML THE QC AFTER THE PATIENT SAMPLE RUN WAS OUT OF RANGE, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077867 ↗
• MalfunctionJan 13, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TSH, ELECSYS T4, ELECSYS FT3 III, AND ELECSYS FT4 IV RESULTS FOR 2 PATIENT SAMPLES ON TWO COBAS E 801 MODULES. FOR SAMPLE 1, THE INITIAL TSH RESULT WAS 0.014 UIU/ML AND THE INITIAL T4 RESULT WAS 0.5 UG/DL. THE REPEAT TSH RESULT WAS 0.833 UIU/ML AND THE REPEAT T4 RESULT WAS 11.4 UG/DL. FOR SAMPLE 2, THE INITIAL TSH RESULT WAS 0.018 UIU/ML, THE INITIAL FT3 RESULT WAS 1.07 PG/ML, THE INITIAL FT4 RESULT WAS 0.04 NG/DL. THE REPEAT TSH RESULT WAS 3.230 UIU/ML, THE REPEAT FT3 RESULT WAS 3.49 PG/ML, AND THE REPEAT FT4 RESULT WAS 1.22 NG/DL. CLARIFICATION ON WHICH MODULE PRODUCED WHICH RESULTS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058685 ↗
• MalfunctionJan 9, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCTREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T HS ASSAY ON A COBAS E 801 MODULE. PATIENT 1: THE INITIAL RESULT WAS 230 NG/L. THE SAMPLE WAS REPEATED TWICE ON 2 DIFFERENT COBAS ANALYZERS, AND THE REPEAT RESULTS WERE BOTH < 5 NG/L. PATIENT 2 WAS TESTED ON (B)(6) 2025: THE INITIAL RESULT WAS 19.200 NG/L. THE SAMPLE WAS REPEATED TWICE, AND THE REPEAT RESULTS WERE BOTH 3 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019632 ↗
• MalfunctionJan 6, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS ESTRADIOL III RESULTS FOR PATIENT SAMPLES AND QC MATERIAL FROM THE COBAS E 801 MODULE. ONE EXAMPLE WAS AN INITIAL RESULT OF 5.0 OR LESS PG/ML AND REPEAT RESULTS OF 48.9 PG/ ML AND 5.0 OR LESS. THE RESULT OF 5.0 OR LESS WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980364 ↗
• MalfunctionDec 23, 2025High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA19-9 RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 19.4 U/ML, AND THE REPEAT RESULT WAS 35.5 U/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162606. One submission often covers many models, so check the product and lot details in each record.

• Z-0044-2020 · Aug 13, 2019 · Terminated
  AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids)
• Z-1249-2019 · Mar 15, 2019 · Terminated
  cobas e 801 immunoassay analyzer
• Z-2136-2018 · Apr 3, 2018 · Terminated
  cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human bo