cobas e 411 Immunoassay Analyzer 04775201001Recalls & reported problems

Summary

The FDA's MAUDE database contains 685 adverse event reports that list this exact device (DI 04015630924721), received between Jul 12, 2018 and Sep 30, 2026 — classified as 685 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (382 reports).

6 other recalls cover devices cleared under the same FDA submission (K961481); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 685 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947527 ↗
• MalfunctionSep 28, 2026Non Reproducible Results

  There was an allegation of questionable Elecsys Estradiol III Assay results for 1 patient sample on a cobas e 411 analyzer (rack system).The initial result was >3000 pg/mL with a data flag.Because the result had a data flag, the sample was repeated with a (1:10) dilution, and the result was 275.4 pg/mL.The sample was repeated without dilution, and the results were 37.32 pg/mL, 22.74 pg/mL, and 21.43 pg/mL.The result of 21.43 pg/mL was believed to be correct.The results of 22.74 pg/mL and 21.43 pg/mL were obtained using a different reagent pack.The questionable results were not reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914898 ↗
• MalfunctionSep 25, 2026False Positive Result

  There was an allegation of questionable results for multiple assays from the cobas e411 rack analyzer. The samples were repeated on a cobas e 402 analyzer.For the Anti-HAV IgM assay, the Elecsys HBsAg II assay, and the Elecsys HIV combi PT assay, the results were allegedly false positives. No specific data was provided.The questionable results were not reported outside of the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900103 ↗
• MalfunctionSep 24, 2026Incorrect Measurement

  There was an allegation of a questionable Elecsys HCG+¿ result for 1 patient sample on a cobas e 411 analyzer (rack system). The initial result was 0.258 mIU/mL. The repeat result was 28,000 mIU/mL.The sample was repeated after the patient questioned the initial result. The repeat result is deemed to be correct as it corresponds to the patient's clinical picture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883304 ↗
• MalfunctionSep 23, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871473 ↗
• MalfunctionAug 20, 2026Low Test Results; Output Problem; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50345900 ↗
• MalfunctionAug 17, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286348 ↗
• MalfunctionJun 3, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TOTAL PSA RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM) MODULE. THE INITIAL RESULT WAS 0.695 NG/ML. THE REPEAT RESULTS ON (B)(6) 2026 WERE BOTH 0.006 NG/ML, ACCOMPANIED BY DATA FLAGS. THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT WHEN THEY GOT A DIFFERENT RESULT FROM ANOTHER LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25377970 ↗
• MalfunctionMay 22, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE VITAMIN B12 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS >37 PMOL/L. THE REPEAT RESULT WAS 457.9 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257069 ↗
• MalfunctionMay 19, 2026High Test Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HBSAG II ASSAY AND 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HBS ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM). SAMPLE 1 WAS TESTED FOR HBSAG II: INITIAL RESULT: 1.67 (REACTIVE). ON (B)(6) 2026: REPEAT RESULT: 0.641 (NON-REACTIVE). SAMPLE 2 WAS TESTED FOR ANTI-HBS: INITIAL RESULT: <2.00 IU/L (NON-REACTIVE). THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS REPEATED. ON (B)(6) 2026: REPEAT RESULT: >1000 IU/L (REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222863 ↗
• MalfunctionMay 15, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG+BETA AND ELECSYS HIV COMBI PT RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT SAMPLE 1 ELECSYS HIV COMBI PT ON (B)(6) 2026, THE INITIAL RESULT WAS 13.32 COI (REACTIVE). ON (B)(6) 2026, THE REPEAT RESULT WAS 0.346 COI (NON-REACTIVE). PATIENT SAMPLE 2 ELECSYS HCG+BETA ON (B)(6) 2026, THE INITIAL RESULT WAS 10.88 MIU/ML. THE REPEAT RESULT WAS 0.100 MIU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183505 ↗
• MalfunctionMay 5, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TESTOSTERONE II ASSAY (TESTOSTERONE II) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE IS 539.5 NG/DL (18.72 NMOL/L). THE REPEAT RESULT IS 372.9 NG/DL (12.939 NMOL/L) WITH A DATA FLAG. THE RESULT OF A NEW PATIENT SAMPLE IS 38.61 NG/DL (1.34 NMOL/L).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080657 ↗
• MalfunctionApr 29, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TESTOSTERONE II ASSAY ON A COBAS E 411 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT VALUE WAS DEEMED CORRECT. THE SAMPLE INITIALLY RESULTED IN A TESTOSTERONE VALUE OF 8.97 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF 4.29 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027217 ↗
• MalfunctionApr 28, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 10.00 PG/ML WITH A DATA FLAG. THE SAMPLE WAS RERUN TWICE, AND THE RESULTS WERE 84.47 PG/ML AND 84.01 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019419 ↗
• MalfunctionApr 27, 2026Low Test Results; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF A QUESTIONABLE TG G2 ELECSYS RESULT FOR ONE PATIENT FROM THE COBAS E 411 ANALYZER (RACK SYSTEM). 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 25002395 ↗
• MalfunctionApr 27, 2026Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T4 ON A COBAS E 411 ANALYZER (RACK SYSTEM). 2. PATIENT AGE RANGE: 74 YEARS. 3. PATIENT WEIGHT RANGE: 75 KG. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002177 ↗
• MalfunctionApr 27, 2026Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM). INITIAL RESULT: 0.039 NG/DL (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 2.36 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001608 ↗
• MalfunctionApr 22, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HEPATITIS B SURFACE ANTIGEN (HBSAG) RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E 411 ANALYZER (RACK SYSTEM). MULTIPLE PREVIOUS PATIENT SAMPLES WERE REPEATED AND THE RESULTS WERE POSITIVE. THE EXACT RESULTS AND NUMBER OF PATIENT SAMPLES WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953465 ↗
• MalfunctionApr 14, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IGE AND INSULIN RESULTS FOR AN UNSPECIFIED AMOUNT OF PATIENT SAMPLES ON A COBAS E 411 ANALYZER (RACK SYSTEM). ONLY ONE EXAMPLE WAS PROVIDED. IGE: THE INITIAL RESULT WAS 180 IU/ML. THE REPEAT RESULT WAS 520 IU/ML. INSULIN: THE INITIAL RESULT WAS 260 UU/ML. THE REPEAT RESULT WAS 130 UU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876602 ↗
• MalfunctionApr 14, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS VITAMIN B12 II RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 411 ANALYZER (RACK SYSTEM). ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL RESULT OF <36.90 PMOL/L. THE REPEAT RESULT WAS 389.50 PMOL/L. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL RESULT OF<36.90 PMOL/L. THE REPEAT RESULT WAS 206.8 PMOL/L. ANOTHER SAMPLE TUBE COLLECTED AT THE SAME TIME WAS TESTED, AND THE RESULT WAS 238 PMOL/L. THE TWO REPEAT RESULTS WERE DEEMED CORRECT. ON (B)(6) 2026, SAMPLE 3 HAD AN INITIAL RESULT OF <36.90 PMOL/L. THE REPEAT RESULT WAS 220.44 PMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876379 ↗
• MalfunctionApr 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 5.05 MIU/ML (POSITIVE PREGNANCY RESULT). THE FIRST REPEAT RESULT WAS <1.0 MIU/ML WITH A DATA FLAG (NEGATIVE PREGNANCY RESULT). THE SECOND REPEAT RESULT WAS <1.0 MIU/ML WITH A DATA FLAG (NEGATIVE PREGNANCY RESULT). THE QUESTIONABLE POSITIVE PREGNANCY RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862898 ↗
• MalfunctionApr 7, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF A DISCREPANT NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS RUBELLA IGG IMMUNOASSAY (RUBELLA IGG) ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 0.212 IU/ML (NEGATIVE). THE DOCTOR QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED WITH A RESULT OF 119.7 IU/ML (POSITIVE). THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797864 ↗
• MalfunctionApr 6, 2026High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH ELECSYS HCG+BETA ON A COBAS E411 RACK. THE FIRST SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 340.3 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF < 0.100 MIU/ML WITH A DATA FLAG. THE SECOND SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 4.36 MIU/ML ON (B)(6) 2026. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF < 0.1 MIU/ML WITH A DATA FLAG. THE THIRD SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 5.14 MIU/ML WITH A DATA FLAG ON 18-(B)(6) 2026. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF < 0.100 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF < 0.100 MIU/ML WITH A DATA FLAG. THE FOURTH SAMPLE INITIALLY RESULTED IN AN HCG+BETA VALUE OF 9.60 MIU/ML WITH A DATA FLAG ON (B)(6) 2026. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF < 0.100 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF < 0.100 MIU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788858 ↗
• MalfunctionApr 1, 2026Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE VITAMIN B12 ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS >2000 PG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 80.5 PG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755021 ↗
• MalfunctionApr 1, 2026Insufficient Device Problem Information

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TSH ASSAY AND ELECSYS FT4 G4 ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM). TSH: INITIAL RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 1ST REPEAT RESULT: 0.005 UIU/ML (ACCOMPANIED BY A DATA FLAG). 2ND REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 3RD REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 4TH REPEAT RESULT: 0.005 UIU/ML (ACCOMPANIED BY A DATA FLAG). 5TH REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 6TH REPEAT RESULT: 1.6 UIU/ML (TESTED IN A DIFFERENT LABORATORY). FT4: INITIAL RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 1ST REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 2ND REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 3RD REPEAT RESULT: "NO VALUE" WAS GENERATED AND (ACCOMPANIED BY A "<SIGNAL" DATA FLAG). 4TH REPEAT RESULT: 16 PMOL/L (TESTED IN A DIFFERENT LABORATORY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753443 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961481. One submission often covers many models, so check the product and lot details in each record.

• Z-0499-2018 · Jul 5, 2017 · Terminated
  Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 -
• Z-0095-2017 · Jul 15, 2016 · Terminated
  cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a contr
• Z-1790-2014 · May 21, 2014 · Terminated
  Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Produc
• Z-1218-2012 · Jan 31, 2012 · Terminated
  Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.
• Z-0165-2009 · Jun 24, 2008 · Terminated
  Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
• Z-0868-2008 · Mar 21, 2008 · Terminated
  Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitr