Bilirubin Total Gen.3Recalls & reported problems across all models

We found 4 models of Bilirubin Total Gen.3 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2023 and Sep 29, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 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 Bilirubin Total Gen.3 problems

Bilirubin Total Gen.3 models

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

• Bilirubin Total Gen.3 08056960190

  DIAZO COLORIMETRY, BILIRUBIN
  14 reports
• Bilirubin Total Gen.3 10421436190

  DIAZO COLORIMETRY, BILIRUBIN
  4 reports
• Bilirubin Total Gen.3 10421410190

  DIAZO COLORIMETRY, BILIRUBIN
  1 report
• Bilirubin Total Gen.3 10421428190

  DIAZO COLORIMETRY, BILIRUBIN
  1 report

Recent Bilirubin Total Gen.3 adverse event reports

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

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937364 ↗
• MalfunctionSep 11, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734674 ↗
• MalfunctionAug 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233417 ↗
• MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR BILT3 BILIRUBIN TOTAL GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 40.3 UMOL/L. THE INITIAL RESULT WAS HELD DUE TO AUTO-VALIDATION RULES. THE REPEAT RESULT WAS 4.36 UMOL/L AND WAS AUTO-VERIFIED. THE INITIAL RESULT WAS BELIEVED TO BE CORRECT. THE REPEAT RESULT IS IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367589 ↗
• MalfunctionFeb 9, 2026Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.0 UMOL/L. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN VALUES OF 214 UMOL/L AND 213 UMOL/L. THE SAMPLE WAS ALSO REPEATED ON THE COBAS C 303 INSTRUMENT AND THE RESULT WAS 222 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290479 ↗
• MalfunctionOct 20, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.54 UMOL/L. THE CUSTOMER QUESTIONED THE RESULT AS IT WAS LOWER THAN THE DIRECT BILIRUBIN RESULT. THE SAMPLE WAS REPEATED AND THE RESULT WAS 50.6 UMOL/L WITH FLAG. THE SAMPLE WAS ALSO REPEATED ON ANOTHER COBAS PRO ANALYZER AND THE RESULT WAS CONSISTENT WITH THE FIRST REPEAT RESULT. THE EXACT REPEAT RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337647 ↗
• MalfunctionAug 29, 2025Unable to Obtain Readings; High Test Results; Unable to Obtain Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL TOTAL BILIRUBIN RESULT WAS 0.975 MG/DL ACCOMPANIED BY A FLAG INDICATING THE ASSAY HAS UNSTABLE KINETICS. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 0.6 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926598 ↗
• MalfunctionAug 29, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.391 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PICTURE. THE REPEATED RESULTS WERE 11.1 MG/DL AND 11.2 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924152 ↗
• MalfunctionAug 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS FOR 9 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER OBSERVED HIGH TOTAL BILIRUBIN RESULTS WHICH PROMPTED THEM TO REPEAT PATIENT SAMPLES ON ANOTHER C503 ANALYZER WITH A DIFFERENT REAGENT LOT. FOR SAMPLE 1, THE INITIAL TOTAL BILIRUBIN RESULT WAS 26.7 UMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 7.9 UMOL/L. FOR SAMPLE 2, THE INITIAL TOTAL BILIRUBIN RESULT WAS 34.7 UMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 12.3 UMOL/L. FOR SAMPLE 3, THE INITIAL TOTAL BILIRUBIN RESULT WAS 43 UMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 13.6 UMOL/L. FOR SAMPLE 4, THE INITIAL TOTAL BILIRUBIN RESULT WAS 34.9 UMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 4.7 UMOL/L. FOR SAMPLE 5, THE INITIAL TOTAL BILIRUBIN RESULT WAS 21.9 UMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 11.2 UMOL/L. THE CUSTOMER ALSO PERFORMED PRECISION TESTING ON THE AFFECTED ANALYZER USING PATIENT SAMPLES. FOR SAMPLE 6, THE INITIAL TOTAL BILIRUBIN RESULT WAS 22.4 UMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER TWICE AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904124 ↗
• MalfunctionAug 14, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE AFFECTED PATIENT ALSO HAD QUESTIONABLE BIL-D GEN.2 RESULTS. THIS MEDWATCH WILL APPLY TO THE BILIRUBIN TOTAL GEN.3. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR THE BIL-D GEN.2 ASSAY. THE INITIAL RESULT WAS 5.27 MG/DL, AND THE REPEAT RESULT WAS 17.5 MG/DL. THE SAMPLE WAS REPEATED AGAIN WITH A RESULT OF 5.22 MG/DL. A NEW SAMPLE WAS COLLECTED, AND THE RESULT WAS 17 MG/DL. THE INITIAL RESULT WAS REPEATED BECAUSE IT DID NOT MATCH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806067 ↗
• MalfunctionAug 11, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT ON A COBAS C 503 ANALYTICAL UNIT COMPARED TO A RADIOMETER ABL ANALYZER. THE INITIAL C503 TOTAL BILIRUBIN RESULT WAS 0.3 MG/DL FROM AN ALIQUOTED SAMPLE. ANOTHER SAMPLE COLLECTED AT THE SAME TIME WAS TESTED ON AN ABL ANALYZER AND THE TOTAL BILIRUBIN RESULT WAS 15.2 MG/DL. THE RESULT OF 15.2 MG/DL WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777243 ↗
• MalfunctionJul 18, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH BIL-D GEN.2 (BILD2) ASSAY AND 3 PATIENTS' SAMPLES TESTED WITH BILIRUBIN TOTAL GEN.3 (BILT3) ASSAY AND BIL-D GEN.2 (BILD2) ASSAY ON A COBAS PURE C 303 ANALYTICAL UNIT, A C 501 MODULE AND, AN INTEGRA ANALYZER COMPARED TO THE SIEMENS METHOD. THIS MEDWATCH WILL APPLY TO THE BILT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE BILD2 ASSAY. PATIENT 1: BILD2: INITIAL RESULT: 0.894 MG/DL (TESTED ON PURE C 303). 1ST REPEAT RESULT: 0.215 MG/DL (TESTED ON COBAS INTEGRA). 2ND REPEAT RESULT: 0.334 MG/DL (TESTED ON COBAS C501). 3RD REPEAT RESULT: 0.21 MG/DL (TESTED ON SIEMENS). PATIENT 2: BILD2: INITIAL RESULT: 0.615 MG/DL (TESTED ON PURE C 303). 1ST REPEAT RESULT: 0.342 MG/DL (TESTED ON COBAS INTEGRA). 2ND REPEAT RESULT: 0.468 MG/DL (TESTED ON COBAS C501). 3RD REPEAT RESULT: 0.24 MG/DL (TESTED ON SIEMENS). PATIENT 3: BILT3: INITIAL RESULT: 0.118 MG/DL (TESTED ON PURE C 303). 1ST REPEAT RESULT: 0.113 MG/DL (TESTED ON COBAS INTEGRA). 2ND REPEAT RESULT: 0.135 MG/DL (TESTED ON COBAS C501). 3RD REPEAT RESULT: 0.21 MG/DL (TESTED ON SIEMENS). BILD2: INITIAL RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541356 ↗
• MalfunctionJul 15, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR FOUR PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. PATIENT 1: THE INITIAL RESULT WAS 24.4 MG/DL, AND THE REPEATED RESULT WAS 1.4 MG/DL. PATIENT 2: ON (B)(6) 2025, THE INITIAL RESULT WAS 0.9 MG/DL, AND THE REPEATED RESULT WAS 2.4 MG/DL. PATIENT 3: ON (B)(6) 2025, THE INITIAL RESULT WAS 14.20 MG/DL, AND THE REPEATED RESULT WAS 0.7 MG/DL. PATIENT 4: ON (B)(6) 2025, THE INITIAL RESULT WAS 6.20 MG/DL, AND THE REPEATED RESULT WAS 0.3 MG/DL. THE SAMPLES WERE REPEATED BECAUSE THE PHYSICIAN QUESTIONED THE INITIAL RESULTS DUE TO THE RESULTS NOT MATCHING THE PATIENT'S CLINICAL HISTORY. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511353 ↗
• MalfunctionMay 30, 2025Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE BILIRUBIN TOTAL GEN.3 ASSAY RESULTS FROM THREE SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 402 ANALYTICAL UNIT. ON (B)(6) 2025: THE INITIAL RESULT OF THE FIRST PATIENT SAMPLE FROM A HEEL STICK WAS 14.3 MG/DL. THE REPORTER REQUESTED THE COLLECTION OF A SECOND PATIENT SAMPLE AS THE HEMOLYSIS INDEX WAS 363. THE INITIAL RESULT OF A SECOND PATIENT SAMPLE FROM A HEEL STICK WAS 21.1 MG/DL. THE REPORTER DEEMED THIS RESULT ERRONEOUS. THE RESULT OF THE THIRD PATIENT SAMPLE OBTAINED BY VENIPUNCTURE WAS 14.9 MG/DL. THE HEMOLYSIS INDEX WAS NOTED TO BE SIGNIFICANTLY LOWER. ON (B)(6) 2025: THE REPEAT RESULT OF THE SECOND PATIENT SAMPLE WAS 12.9 MG/DL. THE CARE PROVIDER QUESTIONED THIS RESULT. THE RESULT OF A FOURTH PATIENT SAMPLE FROM ANOTHER LABORATORY WAS 16.2 MG/DL AND WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112950 ↗
• MalfunctionNov 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 NEONATE PATIENT SAMPLE TESTED FOR COBAS C BILIRUBIN TOTAL GEN.3 (BILT3) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 240 UMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN REQUESTED REPEAT TESTING AND A NEW SAMPLE. THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 130 UMOL/L. THE RESULT FROM THE 2ND SAMPLE WAS 122 UMOL/L WHICH IS CLINICALLY CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636962 ↗

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