Bilirubin Total Gen3 5795419190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630928903), received between Jan 28, 2019 and Jul 24, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION ABOUT A SUSPECTED DRUG INTERFERENCE FOR 1 PATIENT SERUM SAMPLE TESTED WITH BIL-T GEN.3 (BILT3) ASSAY ON A COBAS 8000 COBAS C701 MODULE. THE CUSTOMER MENTIONED THAT THE SAMPLE WAS ABNORMALLY DARK IN COLOR AND THEY WERE CONCERNED THAT THE DARK COLOR OF THE SERUM MIGHT BE INTERFERING WITH THE TEST. THE BILT3 RESULT WAS 10.2. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS NOT REPEATED. THE CUSTOMER ALSO MENTIONED THAT THE SERUM INDEX (SI) WAS NORMAL: HEMOLYSIS: 20. ICTERUS: 4. LIPEMIA: 49.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820342 ↗
• MalfunctionMay 2, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE BILIRUBIN TOTAL GEN. 3 RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 2.55 MG/L AND THE REPEAT RESULT ON (B)(6) 2024 WAS 16.63 MG/L. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231591 ↗
• MalfunctionMar 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL BILIRUBIN (BIL-T GEN 3) RESULTS FROM THE COBAS 8000 C702 MODULE. THE RESULT WAS 9.9 MG/DL ON ANOTHER ANALYZER AND THE RESULT ON THIS ANALYZER WAS 0.5 MG/DL. THE CUSTOMER ALSO PROVIDED A RESULT OF 10.4 MG/DL. THE CUSTOMER REPORTED A RESULT OF 10.2 MG/DL THAT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865253 ↗
• MalfunctionApr 24, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH BILT3 BILIRUBIN TOTAL GEN.3 ON COBAS 8000 C (701) MODULE SERIAL NUMBER (B)(6) , A COBAS 6000 C (501) MODULE (SERIAL NUMBER UNKNOWN), AND AN UNKNOWN ROCHE ANALYZER (SERIAL NUMBER UNKNOWN). THE PATIENT SAMPLE WAS NOTED TO BE BROWN IN COLOR AND THE REPORTER ALLEGES IT MAY CONTAIN AN INTERFERING FACTOR AGAINST A COMPONENT OF THE TOTAL BILIRUBIN ASSAY. THE REPORTER ALSO NOTED THAT THE SAME ISSUE HAS OCCURRED WITH THIS PATIENT BEFORE. THE PLASMA TUBE OF THE PATIENT SAMPLE INITIALLY RESULTED IN A TOTAL BILIRUBIN VALUE OF 0.7 MG/DL WHEN TESTED ON THE C 701 ANALYZER. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PLASMA AND SERUM TUBES OF THE PATIENT SAMPLE WERE REPEATED ON THE C 501 ANALYZER AND ALL TOTAL BILIRUBIN RESULTS WERE 0.7 MG/DL. THE SERUM SAMPLE WAS THEN SENT TO A SECOND SITE WHERE IT WAS TESTED ON AN UNKNOWN ROCHE ANALYZER, RESULTING IN A TOTAL BILIRUBIN VALUE OF 0.7 MG/DL. THE SERUM SAMPLE WAS SENT TO A THIRD SITE WHERE IT WAS TESTED ON A BECKMAN COULTER AU680 ANALYZER, RESULTING IN A TOTAL BILIRUBIN VALUE OF 3.6 MG/DL. THE SERUM SAMPLE WAS ALSO SENT TO A FOURT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797144 ↗
• MalfunctionJan 28, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS 8000 C 702 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE ERRONEOUS RESULT FOR BILT3 BILIRUBIN TOTAL GEN.3. THE PATIENT'S AGE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THERE PATIENT'S GENDER WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8281240 ↗

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