Triglycerides/Glycerol Blanked 05976006190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630928125), received between Sep 21, 2018 and Sep 21, 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 21, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF LOW DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR TRIGB TRIGLYCERIDES/GLYCEROL BLANKED (TRIGB) ON A COBAS 8000 C 702 MODULE. PATIENT 1 INITIAL TRIGB RESULT WAS 319 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. ON (B)(6) 2018 THE SAMPLE WAS REPEATED AND THE RESULT WAS 232 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH AUTO-DILUTION AND THE RESULT WAS 4121 MG/DL. ON (B)(6) 2018 PATIENT 2 (FEMALE, (B)(6)) INITIAL TRIGB RESULT WAS 558 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. ON (B)(6) 2018 THE SAMPLE WAS REPEATED AND THE RESULT WAS 514 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH AUTO-DILUTION AND THE RESULT WAS 3511 MG/DL. ON (B)(6) 2018 PATIENT 3 (FEMALE, (B)(6)) INITIAL TRIGB RESULT WAS 681 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. THE SAMPLE WAS REPEATED WITH AUTO-DILUTION AND THE RESULT WAS 3337 MG/DL. THE REPEAT RESULTS USING AUTO-DILUTION WERE BELIEVED TO BE CORRECT. NO ADVERSE EVENT OCCURRED. THE C702 MODULE SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE ENGINEER (FSE) VISITE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898155 ↗

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.