Bilirubin Total Gen.3 08056960190Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613336121078), received between Aug 29, 2023 and Oct 20, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 31, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS C BILIRUBIN TOTAL GEN.3 RESULTS FOR PATIENT SAMPLES AND QC MATERIAL FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THE ISSUE BEGAN WITH A NEW REAGENT PACK. EXAMPLE 1 WAS AN INITIAL RESULT OF 1.41 MG/DL AND A REPEAT RESULT OF 0.249 MG/DL. EXAMPLE 2 WAS AN INITIAL RESULT OF 1.27 MG/DL AND A REPEAT RESULT OF 0.745 MG/DL. EXAMPLE 3 WAS AN INITIAL RESULT OF 1.42 MG/DL AND A REPEAT RESULT OF 0.793 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578301 ↗
• MalfunctionJun 28, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH COBAS C BILIRUBIN TOTAL GEN.3 WITH A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER NOTED THAT THE SAMPLE APPEARED VERY DARK, BUT THERE WERE NO ALARMS INDICATING HEMOLYSIS, ICTERUS, OR LIPEMIA. THE SAMPLE INITIALLY RESULTED IN A TOTAL BILIRUBIN VALUE OF 0.491 MG/DL. THE SAMPLE WAS REPEATED ON A BLOOD GAS ANALYZER, RESULTING IN A TOTAL BILIRUBIN VALUE OF 1.98 MG/DL. THE SAMPLE WAS ALSO REPEATED USING A COMPETITOR PHOTOMETRIC METHOD, RESULTING IN A TOTAL BILIRUBIN VALUE OF 1.85 MG/DL. THIS VALUE ALIGNED MORE CLOSELY WITH THE CLINICAL PRESENTATION OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633213 ↗
• MalfunctionMar 22, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR COBAS C BILIRUBIN TOTAL GEN.3 (BILT3) ON A COBAS INTEGRA 400 PLUS ANALYZER AND A C503 ANALYZER USED AT A DIFFERENT SITE. THE PATIENT IS BEING TESTED AT THE CUSTOMER SITE WITH NORMAL BILT3 RESULTS. DIFFERENT SAMPLES FROM THIS PATIENT WERE TESTED AT A DIFFERENT SITE USING A COMPETITOR METHOD AND THE TOTAL BILIRUBIN RESULTS WERE HIGH. ON (B)(6) 2024 THE RESULT FROM THE 400 PLUS ANALYZER WAS 0.8 MG/DL. ON (B)(6)2024 THE REPEAT RESULT FROM A C503 ANALYZER AT A DIFFERENT SITE WAS 0.7 MG/DL. ON (B)(6) 2024 THE RESULTS FROM THE COMPETITOR METHOD WERE 4.1 MG/DL AND 4.1 MG/DL. ON (B)(6) 2024 THE RESULT FROM THE COMPETITOR METHOD WAS 3.8 MG/DL. ON (B)(6) 2024 THE RESULT FROM THE COMPETITOR METHOD WAS 3.3 MG/DL. ON (B)(6) 2024 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE 400 PLUS ANALYZER WAS 0.7 MG/DL. ON (B)(6) 2024 THIS SAMPLE WAS REPEATED ON A C503 ANALYZER WITH A RESULT OF 0.660 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959779 ↗
• MalfunctionDec 19, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL BILIRUBIN RESULT FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 33.6 MG/L AND THE REPEAT RESULT WAS 125 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357462 ↗
• MalfunctionAug 29, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO AN ABL90 BLOOD GAS ANALYZER. THE CUSTOMER INITIALLY QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE PATIENT SAMPLE WAS BROWN IN COLOR AND HAD A "JAUNDICE INDEX OF 3." THE PATIENT'S DOCTOR DID NOT SEE ANY SIGNS OF JAUNDICE IN THE PATIENT. THE INITIAL BILT3 RESULT WAS 0.97 MG/DL. THE SAMPLE WAS ALSO RUN ON AN ABL90 BLOOD GAS ANALYZER AND THE RESULT WAS 2.8 MG/DL. A 1:2 AND A 1:4 SERIAL DILUTION WERE PERFORMED OBTAINING TOTAL BILIRUBIN RESULTS OF 0.9 MG/DL ON THE SAME COBAS PRO. A REPEAT TOTAL VALUE OF 0.944 MG/DL WAS ALSO PROVIDED. CLARIFICATION WAS REQUESTED ON IF THIS RESULT WAS OBTAINED FROM A DILUTED SAMPLE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644860 ↗

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