Bilirubin Total Gen.3 10421436190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336235522), received between Feb 9, 2026 and Sep 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937364 ↗
• MalfunctionSep 11, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734674 ↗
• MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR BILT3 BILIRUBIN TOTAL GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 40.3 UMOL/L. THE INITIAL RESULT WAS HELD DUE TO AUTO-VALIDATION RULES. THE REPEAT RESULT WAS 4.36 UMOL/L AND WAS AUTO-VERIFIED. THE INITIAL RESULT WAS BELIEVED TO BE CORRECT. THE REPEAT RESULT IS IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367589 ↗
• MalfunctionFeb 9, 2026Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.0 UMOL/L. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN VALUES OF 214 UMOL/L AND 213 UMOL/L. THE SAMPLE WAS ALSO REPEATED ON THE COBAS C 303 INSTRUMENT AND THE RESULT WAS 222 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290479 ↗

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