Bilirubin Total Gen3 5795648190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630928910), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible 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.

• MalfunctionApr 25, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. NON-REPRODUCIBLE RESULTS WERE GENERATED BY THE COBAS C 111. THE EVENT INVOLVED A TOTAL OF 2 PATIENTS TESTED FOR BILT3 BILIRUBIN TOTAL GEN.3.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549733 ↗

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