Bilirubin Direct Gen.2 08056951190Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613336121061), received between Dec 26, 2024 and Sep 30, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946532 ↗
• MalfunctionAug 11, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208111 ↗
• MalfunctionAug 11, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206459 ↗
• MalfunctionApr 2, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED WITH BIL-D GEN.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 0.448 MG/DL. REPEAT RESULT: 0.10 MG/DL (TESTED ON A COBAS PURE ANALYZER). SAMPLE 2: INITIAL RESULT: 0.554 MG/DL. REPEAT RESULT: 0.14 MG/DL. SAMPLE 3: INITIAL RESULT: 0.56 MG/DL. REPEAT RESULT: 0.17 MG/DL. THE CUSTOMER NOTICED THAT THE DIFFERENCE BETWEEN THE BILIRUBIN TOTAL AND THE INITIAL BILIRUBIN DIRECT RESULTS WAS NEGATIVE, PROMPTING THE REPEAT OF SAMPLE 1 AND SAMPLE 2 ON A COBAS PURE ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS OBTAINED ON COBAS PURE WERE DEEMED TO BE CORRECT, AS THE BILIRUBIN DIRECT RESULTS WERE LOWER IN VALUE THAN THE BILIRUBIN TOTAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767697 ↗
• MalfunctionJan 22, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BIL-D GEN.2 RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. SAMPLE 1 (B)(6) 2026): THE INITIAL RESULT WAS 0.953 MG/DL. THE SAMPLE WAS REPEATED 5 TIMES AND THE RESULTS WERE 0.131 MG/DL, 0.139 MG/DL, 0.128 MG/DL, 0.129 MG/DL, AND 0.133 MG/DL. THE SAMPLE WAS REPEATED 5 MORE TIMES AND THE RESULTS WERE 0.132 MG/DL, 0.128 MG/DL, 0.134 MG/DL, 0.135 MG/DL, AND 0.132 MG/DL. THE SAMPLE WAS REPEATED ONCE MORE AND THE RESULT WAS 0.136 MG/DL. SAMPLE 2 (B)(6) 2026): THE INITIAL RESULT WAS 0.757 MG/DL. THE SAMPLE WAS REPEATED 5 TIMES AND THE RESULTS WERE 0.239 MG/DL, 0.231 MG/DL, 0.232 MG/DL, 0.232 MG/DL, AND 0.229 MG/DL. THE SAMPLE WAS REPEATED 5 MORE TIMES AND THE RESULTS WERE 0.231 MG/DL, 0.228 MG/DL, 0.228 MG/DL, 0.233 MG/DL OR 0.223 MG/DL, AND 0.231 MG/DL. THE SAMPLE WAS REPEATED TWO MORE TIMES AND THE RESULTS WERE 0.228 MG/DL AND 0.224 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148831 ↗
• MalfunctionDec 18, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BIL-D GEN.2 RESULTS FROM THE COBAS PURE C303 ANALYZER. THE CUSTOMER ALLEGED THE RESULTS FOR NEWBORN PATIENTS UNDERGOING PHOTOTHERAPY WERE SIGNIFICANTLY HIGHER ON THE COBAS PURE C 303 SYSTEM THAN THE RESULTS FROM A COMPETITOR SYSTEMS (E.G. SIEMENS) OR FROM A COBAS C 501 OR COBAS INTEGRA 400 PLUS. THE FOLLOWING EXAMPLE WAS PROVIDED: SAMPLE 1 (NEONATE): THE RESULT FROM THE COBAS C 303 WAS 1.13 MG/DL. THE RESULT FROM A COBAS C503 WAS 1.02 MG/DL. THE RESULT FROM A COBAS C501 WAS 0.90 MG/DL. THE RESULT FROM A NON-ROCHE METHOD WAS 0.34 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE NON-ROCHE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840135 ↗
• MalfunctionDec 3, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR BIL-D GEN.2 (BILD2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 11.8 UMOL/L. THE REPEAT RESULT WAS 8.6 UMOL/L. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT WITH A RESULT OF 3.5 UMOL/L. THE CUSTOMER PERFORMED DAILY MAINTENANCE ON ANOTHER COBAS INSTRUMENT AND REPEATED THE SAMPLE WITH A RESULT OF 3.47 UMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703924 ↗
• MalfunctionOct 29, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH BIL-D GEN.2 ASSAY ON A COBAS PURE C 303 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: 7.6 UMOL/L (TESTED WITH DOUMAS METHOD). REPEAT RESULT: 2.2 UMOL/L (TESTED ON BECKMAN COULTER USING JENDRASSIK-GROF METHOD). SAMPLE 2 WAS TESTED ON AN UNKNOWN DATE: INITIAL RESULT: 10 UMOL/L (TESTED WITH DOUMAS METHOD). REPEAT RESULT: 4.6 UMOL/L (TESTED ON BECKMAN COULTER USING JENDRASSIK-GROF METHOD). THE INITIAL RESULTS DID NOT CORRELATE WITH THE PATIENTS' MEDICAL HISTORY, PROMPTING THE REPEAT OF THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414213 ↗
• MalfunctionSep 18, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BIL-D GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL BIL-D RESULT WAS 0.7 MG/DL. THE CUSTOMER REPLACED THE REAGENT WITH A NEW REAGENT PACK OF THE SAME LOT NUMBER AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 0.16 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087913 ↗
• MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE BIL-D GEN.2 RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: ON (B)(6) 2025: THE INITIAL RESULT WAS 0.569 MG/DL. THE SAMPLE WAS REPEATED 5 TIMES AND GENERATED RESULTS OF 0.187 MG/DL, 0.187 MG/DL, 0.183 MG/DL, 0.183 MG/DL, AND 0.184 MG/DL. THE SAMPLE WAS REPEATED 5 MORE TIMES AND GENERATED RESULTS OF 0.190 MG/DL, 0.198 MG/DL, 0.191 MG/DL, 0.192 MG/DL, AND 0.191 MG/DL. SAMPLE 2: ON (B)(6) 2025: THE INITIAL RESULT WAS 3.460 MG/DL. THE REPEAT RESULT WAS 0.112 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037889 ↗
• MalfunctionAug 14, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE BIL-D GEN.2 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE AFFECTED PATIENT ALSO HAD QUESTIONABLE BILIRUBIN TOTAL GEN.3 RESULTS. THIS MEDWATCH WILL APPLY TO THE BIL-D GEN.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE BILIRUBIN TOTAL GEN.3 ASSAY. THE INITIAL RESULT WAS 0.584 MG/DL, AND THE REPEAT RESULT WAS 1.53 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 22806163 ↗
• 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 BILD2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE BILT3 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 22541138 ↗
• MalfunctionJun 11, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE BIL-D GEN.2 (BILD2) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. PATIENT SAMPLE 1: ON (B)(6) 2025: THE INITIAL RESULT WAS 0.789 MG/DL. THE REPEAT RESULT WAS 0.312 MG/DL. THE REPEAT RESULT WAS 0.309 MG/DL. PATIENT SAMPLE 2: ON (B)(6) 2025: THE HIGH RESULT WAS 0.488 MG/DL. THE REPEAT RESULT WAS 0.161 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182981 ↗
• MalfunctionMar 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN.3 AND BIL-D GEN.2 RESULTS FROM THE COBAS C 303 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER BIL-D GEN.2. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE BILIRUBIN TOTAL GEN.3. PATIENT 1'S BILIRUBIN DIRECT RESULT ON THE C303 WAS 8.63 UMOL/L, AND THE RESULT FROM THE VITROS ANALYZER WAS 0 UMOL/L. PATIENT 2'S BILIRUBIN DIRECT RESULT ON THE C303 WAS 18.5 UMOL/L, AND THE RESULT FROM THE VITROS ANALYZER WAS 0 UMOL/L. AN ADDITIONAL RESULT OF 22.0 UMOL/L WAS PROVIDED; IT WAS UNCLEAR WHICH PATIENT THIS RESULT IS REGARDING. CLARIFICATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697496 ↗
• MalfunctionMar 17, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BIL-D GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.07 MG/DL. THE REPEATED RESULT WAS 0.135 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619535 ↗
• MalfunctionJan 17, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE BIL-D GEN.2 (BILD2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER NOTED THAT THE BILD2 RESULTS WERE DECREASING. THE INITIAL BILD2 RESULT WAS 14.4 UMOL/L (0.8424 MG/DL). THE TOTAL BILIRUBIN RESULT WAS 11.2 UMOL/L. THE FIRST BILD2 REPEAT RESULT WAS 11.2 UMOL/L (0.6552 MG/DL). THE TOTAL BILIRUBIN RESULT WAS 10.4 UMOL/L. THE SECOND BILD2 REPEAT RESULT WAS 6.8 UMOL/L (0.3978 MG/DL). THE THIRD BILD2 REPEAT RESULT WAS 1.9 UMOL/L WITH A DATA FLAG (0.11115 MG/DL). THE FOURTH BILD2 REPEAT RESULT WAS 11.2 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179021 ↗
• MalfunctionDec 26, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH BIL-D GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A DIRECT BILIRUBIN VALUE OF 2.90 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN THE FOLLOWING VALUES: 0.136 MG/DL, 0.124 MGDL, 0.131 MG/DL, 0.135 MG/DL, 0.134 MG/DL, 0.136 MG/DL, 0.135 MG/DL, 0.136 MG/DL, 0.132 MG/DL, 0.134 MG/DL, 0.128 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A DIRECT BILIRUBIN VALUE OF 0.944 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN THE FOLLOWING VALUES: 0.152 MG/DL, 0.149 MG/DL, 0.151 MG/DL, 0.142 MG/DL, 0.146 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019047 ↗