Bilirubin Total Gen3Recalls & reported problems across all models

We found 3 models of Bilirubin Total Gen3 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2018 and Sep 2, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 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 Gen3 problems

Bilirubin Total Gen3 models

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

• Bilirubin Total Gen3 5795397190

  DIAZO COLORIMETRY, BILIRUBIN
  16 reports
• Bilirubin Total Gen3 5795419190

  DIAZO COLORIMETRY, BILIRUBIN
  5 reports
• Bilirubin Total Gen3 5795648190

  DIAZO COLORIMETRY, BILIRUBIN
  1 report

Recent Bilirubin Total Gen3 adverse event reports

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

• MalfunctionSep 2, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563900 ↗
• MalfunctionDec 15, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. AT 11:24 AM, THE INITIAL SERUM BILIRUBIN RESULT WAS 345.1 MOL/L. AT 4:30 PM, THE INFANT WAS EVALUATED AT ANOTHER HOSPITAL, WHERE A NEW BLOOD SAMPLE WAS COLLECTED. THE BILIRUBIN RESULT WAS 228 MOL/L. TWO DAYS LATER, THE REPEAT BILIRUBIN RESULT WAS 188 MOL/L. IT WAS UNCLEAR IF THIS RESULT WAS GENERATED FROM ONE OF THE THESE SAMPLES OR FROM A NEWLY COLLECTED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802333 ↗
• MalfunctionApr 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 NEONATE PATIENT SAMPLE TESTED FOR BILIRUBIN TOTAL GEN.3 (BILT3) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 14.6 UMOL/L. THIS RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION, AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 183.5 UMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752747 ↗
• MalfunctionFeb 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH BILIRUBIN TOTAL GEN.3 (BILT3) ASSAY ON A COBAS 6000 C501 MODULE. SAMPLE 1: INITIAL RESULT: 71.6 UMOL/L. THE SAMPLE WAS REPEATED AND THE REPEAT RESULTS WERE 8.5 UMOL/L, 43.7 UMOL/L, 12.7 UMOL/L, AND 18.7 UMOL/L. ON (B)(6)2025, A NEW SAMPLE (SAMPLE 2) WAS DRAWN AND TESTED. INITIAL RESULT: 6.6 UMOL/L. THE SERUM SAMPLE WAS REPEATED AND THE REPEAT RESULTS WERE 10.2 UMOL/L AND 27.7 UMOL/L. THE PLASMA SAMPLE WAS REPEATED AND THE REPEAT RESULTS WERE 11.1 UMOL/L AND 8.9 UMOL/L. THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431931 ↗
• MalfunctionFeb 20, 2025Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH BIL-T GEN.3 (BILT3) ASSAY ON A COBAS 6000 C501 (UL) V MODULE. INITIAL RESULT: <0.2 MG/DL (USING MICRO SAMPLE CUPS). THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 13.3 MG/DL (USING A FALSE BOTTOM TUBE). THE REPEAT RESULT WAS DEEMED TO BE CORRECT AS IT MATCHED THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421844 ↗
• MalfunctionJan 8, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT NEONATE SAMPLE TESTED FOR BILIRUBIN TOTAL GEN. 3 (BIL-T) ON A COBAS C 311 ANALYZER. THE INITIAL RESULT WAS 1.3 MG/DL. THE SAMPLE WAS REPEATED AS THE RESULT WAS "SIGNIFICANTLY" DIFFERENT THAN THE PREVIOUS RESULT FOR THIS PATIENT. THE REPEAT FROM A DIFFERENT C311 ANALYZER WAS 13.2 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105869 ↗
• MalfunctionJul 24, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT A SUSPECTED DRUG INTERFERENCE FOR 1 PATIENT SERUM SAMPLE TESTED WITH BIL-T GEN.3 (BILT3) ASSAY ON A COBAS 8000 COBAS C701 MODULE. THE CUSTOMER MENTIONED THAT THE SAMPLE WAS ABNORMALLY DARK IN COLOR AND THEY WERE CONCERNED THAT THE DARK COLOR OF THE SERUM MIGHT BE INTERFERING WITH THE TEST. THE BILT3 RESULT WAS 10.2. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS NOT REPEATED. THE CUSTOMER ALSO MENTIONED THAT THE SERUM INDEX (SI) WAS NORMAL: HEMOLYSIS: 20. ICTERUS: 4. LIPEMIA: 49.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820342 ↗
• MalfunctionMay 22, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SAMPLE TESTED WITH BILIRUBIN TOTAL GEN.3 (BILT3) ASSAY ON A COBAS 8000 COBAS C502 MODULE NOT MATCHING THE PATIENT'S CLINICAL EXAMINATION. THE PATIENT HAD SEVERAL BILT3 RESULTS RANGING BETWEEN 0.24 MG/DL AND 0.34 MG/DL AND WERE CONSIDERED WITHIN THE NORMAL RANGE OF A HEALTHY PERSON. THE PATIENT WAS TESTED IN ANOTHER LABORATORY WITH A COMPETITOR'S (ABBOTT ARCHITECT) METHOD RESULTING IN A BILIRUBIN VALUE OF 0.2 MG/DL WHICH WAS ALSO CONSIDERED WITHIN THE NORMAL RANGE. THE PATIENT HAD A SONOGRAPHIC AND RADIOLOGICAL EXAMINATION OF AN ENLARGEMENT OF BOTH THE INTRAHEPATIC AND THE EXTRAHEPATIC BILE DUCT SYSTEM IN THE SENSE THAT A BILE REFLUX WAS DETECTED. THE BILT3 RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE CUSTOMER QUESTIONED WHETHER THE BILT3 RESULTS COULD BE USED TO DIAGNOSE BILE REFLUX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372302 ↗
• MalfunctionMay 8, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT ON A COBAS 6000 C501 MODULE COMPARED TO A RADIOMETER BLOOD GAS ANALYZER. THE DOCTOR QUESTIONED THE LOW ROCHE RESULTS COMPARED TO THE BLOOD GAS ANALYZER RESULTS AS THEY DO NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE PATIENT HAD THE FOLLOWING BILT3 SERUM SAMPLE RESULTS FROM THE C501 MODULE: ON (B)(6) 2024 THE RESULT WAS 1.41 MG/DL. ON (B)(6) 2024 THE RESULT WAS 1.04 MG/DL. ON (B)(6) 2024 THE RESULT WAS 0.69 MG/DL. ON (B)(6) 2024 THE RESULT WAS 0.57 MG/DL. THE PATIENT HAD THE FOLLOWING CAPILLARY SAMPLE RESULTS FROM THE BLOOD GAS ANALYZER: ON (B)(6) 2024 THE RESULT WAS 4.7 MG/DL. ON (B)(6) 2024 THE RESULT WAS 3.9 MG/DL. ON (B)(6) 2024 THE RESULT WAS 3.0 MG/DL. ON (B)(6) 2024 THE RESULT WAS 3.1 MG/DL. CLARIFICATION ON IF THE CAPILLARY SAMPLE WAS COLLECTED AT THE SAME TIME AS THE SERUM SAMPLE WAS REQUESTED. THE ROCHE REFERENCE RANGE IS <1.2 MG/DL FOR ADULTS. THE RADIOMETER REFERENCE RANGE IS <2 MG/DL FOR ADULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273484 ↗
• MalfunctionMay 2, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN. 3 RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 2.55 MG/L AND THE REPEAT RESULT ON (B)(6) 2024 WAS 16.63 MG/L. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231591 ↗
• MalfunctionApr 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL BILIRUBIN (BILT3) RESULT FOR A NEWBORN PATIENT FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 25.29 MG/DL WITH AN ALARM FOR A SAMPLE CLOT ON OTHER ASSAYS TESTED AT THE SAME TIME. THE ATTENDING PHYSICIAN DID NOT AGREE WITH THE RESULT AND REQUESTED REPEAT TESTING. THE REPEAT RESULT WAS 13.98 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033325 ↗
• MalfunctionMar 21, 2024Low Test Results; Insufficient Device Problem Information; Low Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER QUESTIONED LOW RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 2 PATIENT SAMPLES TESTED FOR BILT3 ON A COBAS 8000 C 502 MODULE. AN EXAMPLE WAS PROVIDED FOR 1 PATIENT SAMPLE. THE BILT3 RESULT WAS 0.9 MG/DL. THE SERUM INDEX RESULTS WERE NORMAL BUT THE SAMPLE APPEARED BROWN/GREEN. THE CUSTOMER DID NOT REPEAT THE SAMPLE ON THE C502 MODULE AS THEY DID NOT BELIEVE THE RESULT WOULD BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948325 ↗
• MalfunctionMar 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL BILIRUBIN (BIL-T GEN 3) RESULTS FROM THE COBAS 8000 C702 MODULE. THE RESULT WAS 9.9 MG/DL ON ANOTHER ANALYZER AND THE RESULT ON THIS ANALYZER WAS 0.5 MG/DL. THE CUSTOMER ALSO PROVIDED A RESULT OF 10.4 MG/DL. THE CUSTOMER REPORTED A RESULT OF 10.2 MG/DL THAT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865253 ↗
• MalfunctionFeb 13, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENT'S SAMPLES TESTED WITH BILIRUBIN TOTAL GEN.3 (BILT3) ASSAY ON A COBAS 6000 C501 ANALYZER WHEN COMPARED TO A NON-ROCHE (BECKMAN COULTER (B)(6) ANALYZER. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS OBTAINED BY THE NON-ROCHE ANALYZER WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697129 ↗
• MalfunctionNov 27, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE PATIENT SAMPLE WAS RERUN BECAUSE THE RESULT FROM THE PATIENT'S PREVIOUS SAMPLE WAS 156 UMOL/L. THE INITIAL RESULT WAS 10.8 UMOL/L. THE REPEAT RESULT WAS 209.8 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210069 ↗

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