Bilirubin Total Gen3 5795397190Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04015630928897), received between Aug 13, 2018 and Sep 2, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K131544); 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 21, 2023Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS 6000 C (501) MODULES. THE INITIAL BILT3 RESULTS FROM THE FIRST ANALYZER WERE 2.4 MG/DL AND 2.5 MG/DL. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLE AS THE RESULTS DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER AND THE RESULTS WERE 2.5 MG/DL WITH A PROZONE FLAG AND 0.9 MG/DL. THE RESULT OF 0.9 MG/DL WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182452 ↗
• MalfunctionMay 15, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE NEONATE PATIENT SAMPLE TESTED WITH THE BILT3 (BILIRUBIN TOTAL GEN.3) ASSAY ON A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(6). THE SAMPLE INITIALLY RESULTED IN A BILT3 VALUE OF 9.5 UMOL/L AND REPEATED AS 237.4 UMOL/L. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932101 ↗
• MalfunctionNov 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE BILT3 (BILIRUBIN TOTAL GEN.3) ASSAY ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN A BILT3 VALUE OF 0.39 MG/DL. THE INITIAL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED, RESULTING IN A BILT3 VALUE OF 14.91 MG/DL. THE RE-MEASUREMENT WAS DONE ON THE SAME SAMPLE, SUPPLEMENTED WITH PLASMA. THE BILT3 REAGENT LOT NUMBER WAS 633563 WITH AN EXPIRATION DATE OF 30-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799853 ↗
• MalfunctionAug 13, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR 2 INFANTS THAT WERE TWINS ON A COBAS 6000 C (501) MODULE COMPARED TO A ADVANCED BILIRUBIN STAT-ANALYZER MODEL BR-2. THE C 501 SERIAL NUMBER WAS (B)(4). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INITIAL INVESTIGATION DETERMINED THAT THE CALIBRATION WAS ACCEPTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7778101 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131544. One submission often covers many models, so check the product and lot details in each record.

• Z-0153-2020 · Sep 11, 2019 · Terminated
  Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults an
• Z-1145-2019 · Dec 17, 2018 · Terminated
  Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro te