Elecsys FerritinRecalls & reported problems across all models

We found 3 models of Elecsys Ferritin by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Oct 22, 2018 and Feb 23, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (20 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. 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

Most reported Elecsys Ferritin problems

Elecsys Ferritin models

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

• Elecsys Ferritin 07027273190

  Radioimmunoassay (two-site solid phase), ferritin
  22 reports
• Elecsys Ferritin 3737551160

  Radioimmunoassay (two-site solid phase), ferritin
  4 reports
• Elecsys Ferritin 4491785160

  Radioimmunoassay (two-site solid phase), ferritin
  3 reports

Recent Elecsys Ferritin adverse event reports

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

• MalfunctionFeb 23, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FERRITIN RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 359 NG/ML, AND THE REPEAT RESULT WAS 45.7 NG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER NOTICED THAT THE INITIAL RESULT DID NOT CROSS INTO THE SYSTEM AND WAS HIGH COMPARED TO THE PATIENT'S HISTORY, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421348 ↗
• MalfunctionFeb 12, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324882 ↗
• MalfunctionJan 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.94 NG/ML, AND THE REPEAT RESULT THE NEXT DAY WAS 191.0 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223675 ↗
• MalfunctionNov 19, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 - SEPARATE SAMPLES WERE TESTED: ON (B)(6) 2025, THE RESULT WAS 164 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 223 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 587 NG/ML USING THE ELECSYS ASSAY. PATIENT 2 - TWO SAMPLES FROM THE SAME PATIENT WERE TESTED: ON (B)(6) -2025, THE RESULT WAS 602 NG/ML USING THE ELECSYS ASSAY. ON THE SAME DAY, THE SAME SAMPLE WAS REPEATED AT AN EXTERNAL LABORATORY AND THE RESULT WAS 341 NG/ML USING A CHEMILUMINESCENCE IMMUNOASSAY. ON (B)(6) 2025, THE RESULT WAS 373 NG/ML USING THE ELECSYS ASSAY. ON THE SAME DAY, THE SAME SAMPLE WAS REPEATED AT AN EXTERNAL LABORATORY AND THE RESULT WAS 212 NG/ML USING A CHEMILUMINESCENCE IMMUNOASSAY. PATIENT 3 - SEPARATE SAMPLES WERE TESTED: ON (B)(6) 2025, THE RESULT WAS 392 NG/ML USING THE SIEMENS ASSAY. ON (B)(6) 2025, THE RESULT WAS 508 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 616 NG/ML USING THE ELECSYS ASSAY. ON (B)(6) 2025, THE RESULT WAS 38.4 NG/ML, PERFORMED BY AN EXTERNAL LABORATORY. ON (B)(6) 2025, THE RESULT WAS 590 N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594548 ↗
• MalfunctionSep 10, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH ELECSYS FERRITIN ON A COBAS E 801 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 39 NG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN FERRITIN VALUES OF 9.25 NG/ML AND 9.44 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 63.3 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 47.9 NG/ML AND 39.3 NG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 98.4 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 26.9 NG/ML AND 24.9 NG/ML. THE FOURTH SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 18.1 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 27.3 NG/ML AND 29.5 NG/ML. THE FIFTH SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 28.2 NG/ML ON (B)(6) 2025. THE SAMPLE WAS REPEATED THREE TIMES ON (B)(6) 2025, RESULTING IN FERRITIN VALUES OF 40.4 NG/ML, 14.1 NG/ML, AND 14.5 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018031 ↗
• MalfunctionJun 2, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE RESULT ELECSYS FERRITIN (FERRITIN) ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT OF THE PATIENT'S FIRST SAMPLE WAS 0.846 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 332.0 NG/ML. THE RESULT OF THE PATIENT'S SECOND SAMPLE WAS 334.2 NG/ML. THE NURSE QUESTIONED THE INITIAL RESULT, PROMPTING THE PATIENT'S SAMPLE TO BE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125323 ↗
• MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FERRITIN RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULT FROM THE FIRST E 801 MODULE WAS 21.3 NG/ML. THE FIRST REPEAT RESULT FROM THE SECOND E 801 MODULE WAS 14 NG/ML. THE SECOND REPEAT RESULT FROM A THIRD MODULE WAS 14.2 NG/ML. THE THIRD REPEAT RESULT FROM A FOURTH MODULE WAS 13.4 NG/ML. THE REPORTER STATED THAT THE QUESTIONABLE RESULT WAS DISCOVERED WHILE RESOLVING QC ISSUES AND PERFORMING LOT-TO-LOT STUDIES. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468471 ↗
• MalfunctionJan 28, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FROM THE COBAS E 801 MODULE, THE INITIAL RESULT WAS 158 G/L. THE REPEAT RESULT WAS 97.8 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252437 ↗
• MalfunctionJan 13, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS E801 MODULE. THE REPORTER PROVIDED TWO EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 (PATIENT 1): INITIAL RESULT: 55.1 UG/L. 1ST REPEAT RESULT: 25.8 UG/L. 2ND REPEAT RESULT: 25.2 UG/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 116 UG/L. REPEAT RESULT: 69.4 UG/L. THE CUSTOMER NOTICED THAT THE INITIAL RESULTS WERE HIGH. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE SAMPLES WERE REPEATED. THE REPEAT RESULTS WERE REPORTED TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138260 ↗
• MalfunctionSep 18, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL FERRITIN RESULT WAS 1.33 NG/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED AND THE RESULT WAS 988.4 NG/L. THE SAMPLE WAS ALSO REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 1010 NG/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250780 ↗
• MalfunctionJul 22, 2024High Test Results; Output Problem; High Test Results; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SERUM/PLASMA SAMPLES TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A CHEMILUMINESCENCE METHODOLOGY AT A DIFFERENT FACILITY. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 737 NG/ML. 1ST REPEAT RESULT: 709 NG/ML. 2ND REPEAT RESULT: 422.2 NG/ML (TESTED WITH CHEMILUMINESCENCE). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 375 NG/ML. 1ST REPEAT RESULT: 359 NG/ML. 2ND REPEAT RESULT: 232.0 NG/ML (TESTED WITH CHEMILUMINESCENCE). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 174 NG/ML. REPEAT RESULT: 92.8 NG/ML (TESTED WITH CHEMILUMINESCENCE). THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. THE INITIAL RESULTS WERE CONSIDERED CORRECT AND REPORTED OUTSIDE THE LABORATORY. ONLY 1 PATIENT QUESTIONED THEIR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792657 ↗
• MalfunctionMar 29, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FERRITIN (FERRITIN) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.07 UG/L. THE INITIAL RESULT WAS NOT BELIEVED AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 278 UG/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003604 ↗
• MalfunctionMar 15, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE FERRITIN ELECSYS E2G RESULTS FROM THE COBAS E 801 MODULE. THE RESULT WAS 940 NG/ML. USING A DIFFERENT SAMPLE FROM THE SAME VENIPUNCTURE, THE RESULT FROM AN ABBOTT ANALYZER WAS 594 NG/ML. USING ANOTHER COBAS ANALYZER, THE RESULT WAS 866 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914588 ↗
• MalfunctionJan 18, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS PURE E402 ANALYTICAL UNIT. INITIAL RESULT: 1.69 NG/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE CUSTOMER NOTICED THAT THE RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 49.0 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18538807 ↗
• MalfunctionJan 9, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR 3 PATIENT SAMPLES ON TWO COBAS E 801 ANALYTICAL UNITS. FOR SAMPLE 1, THE INITIAL FERRITIN RESULT WAS 4.93 NG/ML. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 118 NG/ML. FOR SAMPLE 2, THE INITIAL FERRITIN RESULT WAS 1.59 NG/ML. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 30.5 NG/ML. FOR SAMPLE 3, THE INITIAL FERRITIN RESULT WAS 2.66 NG/ML. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 56.0 NG/ML. THE RESULTS FOR SAMPLES 1 AND 2 WERE PRODUCED BY ANALYZER SERIAL NUMBER (B)(6). THE RESULTS FOR SAMPLE 3 WERE PRODUCED BY ANALYZER SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474015 ↗

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