Bilirubin Total Gen.3 10421410190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336235508), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILT3 BILIRUBIN TOTAL GEN.3 RESULTS FOR FOUR PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. PATIENT 1: THE INITIAL RESULT WAS 24.4 MG/DL, AND THE REPEATED RESULT WAS 1.4 MG/DL. PATIENT 2: ON (B)(6) 2025, THE INITIAL RESULT WAS 0.9 MG/DL, AND THE REPEATED RESULT WAS 2.4 MG/DL. PATIENT 3: ON (B)(6) 2025, THE INITIAL RESULT WAS 14.20 MG/DL, AND THE REPEATED RESULT WAS 0.7 MG/DL. PATIENT 4: ON (B)(6) 2025, THE INITIAL RESULT WAS 6.20 MG/DL, AND THE REPEATED RESULT WAS 0.3 MG/DL. THE SAMPLES WERE REPEATED BECAUSE THE PHYSICIAN QUESTIONED THE INITIAL RESULTS DUE TO THE RESULTS NOT MATCHING THE PATIENT'S CLINICAL HISTORY. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511353 ↗

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