Bilirubin Direct Gen.2 (Doumas standardization) 05589061190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630927531), received between May 27, 2025 and Jan 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN DIRECT GEN.2 RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 0.5 MG/DL. THE REPEAT RESULT WAS 0.15 MG/DL AND WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223662 ↗
• MalfunctionAug 25, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN DIRECT GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 4000 C311 STAND ALONE SYSTEM. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL DIRECT BILIRUBIN RESULT OF 1.605 MG/DL. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 1.639 MG/DL. THE DOCTOR QUESTIONED THE RESULT. THE REPEAT RESULT FROM AN EXTERNAL LABORATORY THAT USES AN ABBOTT ANALYZER WAS 0.46 MG/DL. THIS REPEAT RESULT WAS DEEMED CORRECT. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL DIRECT BILIRUBIN RESULT OF 1.969 MG/DL. THE REPEAT RESULT FROM THE EXTERNAL LABORATORY WAS 0.56 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883103 ↗
• MalfunctionMay 27, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE BILIRUBIN DIRECT GEN.2 RESULT FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS 1.025 MG/DL. THE PEDIATRICIAN REQUESTED A NEW BLOOD SAMPLE TO BE ANALYZED AT ANOTHER LABORATORY USING AN ABBOTT ANALYZER. THE RESULT FOR THE NEW SAMPLE WAS 0.50 MG/DL TWICE. ON (B)(6) 2025, THE INITIAL SAMPLE WAS RETESTED ON THE COBAS C311 ANALYZER, AND THE RESULT WAS 1.158 MG/DL. THE SAME INITIAL SAMPLE WAS SENT TO ANOTHER LABORATORY THAT USES AN ABBOTT ANALYZER, AND THE RESULT WAS 0.52 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087186 ↗