Triglycerides 04657594190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630921959), received between Sep 4, 2018 and Sep 4, 2018 — 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 (K873049); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 4, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TRIGL TRIGLYCERIDES (TRIGL) ON A COBAS C 111. THE INITIAL TRIGL RESULT WAS 9.50 MMOL/L WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 AND REPEATED WITH A RESULT OF 3.01 MMOL/L. THE SAMPLE WAS REPEATED NEAT AND THE RESULT WAS 8.97 MMOL/L WITH NO DATA FLAG. THE RESULT OF 8.97 MMOL/L WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS VERY LIPEMIC SO THE HIGH RESULT WAS BELIEVED BY THE TECHNICIAN. ON (B)(6) 2018 A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND THE TRIGL RESULT WAS 0.76 MMOL/L. BASED ON THE LOWER RESULT, THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 3.23 MMOL/L AND THE SAMPLE LOOKED LESS LIPEMIC. THE PATIENT WAS FASTING WHEN BOTH SAMPLES WERE OBTAINED. THE CUSTOMER IS CONFIDENT THERE WAS NO SAMPLE MISMATCH. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C 111 SERIAL NUMBER WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841865 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K873049. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2019 · Dec 14, 2018 · Terminated
  cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product
• Z-1930-2015 · May 7, 2015 · Terminated
  Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.