Triglycerides 20767107322Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630918393), received between Mar 23, 2022 and Sep 30, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Test Results

  We received an allegation about discrepant results for 1 patient sample tested with Triglycerides assay on a COBAS 6000 C (501) Module.The initial result was 594 mg/dL.The customer noticed that the initial result was high and did not match the patient's clinical picture or previous results, prompting a repeat of the sample.The repeat results were:788 mg/dL (accompanied by an invalidating data flag).5651 mg/dL (accompanied by an invalidating data flag).4425 mg/dL.The repeat result of 4425 mg/dL was deemed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947532 ↗
• MalfunctionApr 1, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH MULTIPLE ASSAYS FOR A PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS. THIS MEDWATCH WILL APPLY TO THE TRIGLYCERIDES ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LIPASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CHOLESTEROL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LDL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE HDL ASSAY. INITIAL RESULTS: LIPASE: 8,859 U/L, CHOLESTEROL: 4,074 MG/DL, HDL: 1,611 MG/DL, LDL: 2,077 MG/DL, TRIGLYCERIDES: 3,133 MG/DL. REPEAT RESULTS: LIPASE: 4,678 U/L, CHOLESTEROL: 167 MG/DL, HDL: 69 MG/DL, LDL: 88 MG/DL, TRIGLYCERIDES: 133 MG/DL. REPEAT RESULTS AFTER A 1:10 MANUAL DILUTION: CHOLESTEROL: 196 MG/DL, HDL: 80 MG/DL, LDL: 101 MG/DL, TRIGLYCERIDES: 154 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756833 ↗
• MalfunctionOct 16, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FROM THE COBAS 6000 C (501) MODULE FOR APPROXIMATELY 30 TO 40 PATIENTS. THE CUSTOMER ALLEGES THAT THE TRIGLYCERIDE RESULTS STARTED RUNNING HIGH, 200 MG/DL - 600 MG/DL. THE DOCTORS RECOGNIZED THE HIGH RESULTS AND QUESTIONED THEM. EXACT RESULTS AND REPEAT RESULTS HAVE NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308250 ↗
• MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR TRIGLYCERIDES (TRIGL) ON A COBAS 6000 C501 MODULE. A DISCREPANT HIGH RESULT WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 473.9 MG/DL. THE REPEAT RESULT WAS 311.1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586270 ↗
• MalfunctionOct 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE ASSAYS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON A COBAS 6000 C (501) MODULE. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR TRIGL TRIGLYCERIDES. THE INITIAL RESULT WAS 15 MG/DL. THE REPEAT RESULT WAS 382 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS THE REPORTER RECEIVED NUMEROUS INVALIDATING FLAGGED OR CLOSE TO ZERO ASSAY RESULTS FROM THE ANALYZER, PROMPTING THE PATIENT SAMPLE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408810 ↗
• MalfunctionMar 26, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGL TRIGLYCERIDES RESULTS FROM AN ESTIMATED MINIMUM OF 50 PATIENT SAMPLES TESTED ON TWO COBAS 6000 C501 (UL) V (MODULE 1 AND MODULE 2). THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THE QC WOULD NOT PASS AND THERE WAS A HIGH NUMBER OF PATIENT SAMPLE RESULTS WITH AN INVALIDATING DATA FLAG OR VERY LOW RESULTS, PROMPTING THE RERUN OF PREVIOUS PATIENT SAMPLES ON THEIR OTHER C501 MODULE. THE REPORTER STATED THAT THEY NOTICED THE ISSUE AFTER SERVICE WAS PERFORMED ON THEIR DEIONIZED (DI) WATER SYSTEM. THE INITIAL RESULT FROM MODULE 1 WAS 153 MG/DL. THE REPEAT RESULT FROM MODULE 2 WAS 212 MG/DL. THE REPEAT RESULT COULD NOT BE DETERMINED AS BOTH ANALYZERS WERE AFFECTED BY THE WATER SOURCE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977097 ↗
• MalfunctionOct 23, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGL TRIGLYCERIDES RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. ON (B)(6) 2023, THE INITIAL TRIGL RESULT WAS 413 MG/DL. THE CUSTOMER QUESTIONED THE HIGH RESULT AND REPEATED THE SAMPLE. ON (B)(6) 2023, THE FIRST SAMPLE WAS REPEATED IN A SAMPLE CUP AND THE RESULT WAS 97 MG/DL. ON (B)(6) 2023, THE ORIGINAL SAMPLE TUBE WAS REPEATED TWICE AND THE RESULTS WERE 104 MG/DL AND 106 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986362 ↗
• MalfunctionMar 30, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGL TRIGLYCERIDES RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. FOR PATIENT 1, THE INITIAL TRIGL RESULT WAS 508.9 MG/DL. THE REPEAT RESULT WAS 292.9 MG/DL. FOR PATIENT 2, THE INITIAL TRIGL RESULT WAS 581.2 MG/DL. THE REPEAT RESULT WAS 157.0 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645960 ↗
• MalfunctionJan 3, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FROM THE COBAS 4000 C311 ANALYZER. THE INITIAL RESULT WAS 371.2 MG/DL AND THE REPEAT RESULT WAS 80.0 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED CORRECT. THE REAGENT LOT NUMBER WAS 64844301 WITH AN EXPIRATION DATE OF 31-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087055 ↗
• MalfunctionDec 9, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF CALIBRATION AND QC ISSUES WITH TRIGL TRIGLYCERIDES (TRIGL) ON A COBAS 8000 C 502 MODULE. DUE TO THESE ISSUES, THE CUSTOMER REPEATED PATIENT SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE. THE INITIAL TRIGL RESULT WAS 57 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON 17-NOV-2022 THE REPEAT RESULT WAS 92 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE TRIGL REAGENT LOT NUMBER WAS 64844301 WITH AN EXPIRATION DATE OF 31-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953046 ↗
• MalfunctionNov 29, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TRIGL TRIGLYCERIDES ON A COBAS 4000 C (311) STAND ALONE SYSTEM. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 740.3 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL TREATING THE PATIENT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 125.8 MG/DL. THE REPEAT VALUE WAS CONSIDERED CORRECT. THE TRIGLYCERIDES REAGENT LOT NUMBER WAS 64844301, WITH AN EXPIRATION DATE OF 31-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880353 ↗
• MalfunctionNov 10, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TRIGL (TRIGLYCERIDES) ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN A TRIGL VALUE OF 1286.3 MG/DL. THE SAMPLE WAS REPEATED USING A DILUTION RATIO OF 1.5 AND RESULTED IN A VALUE OF 1721.3 MG/DL. IT WAS NOTED THAT THE SAMPLE WAS LIPEMIC. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE TRIGL REAGENT LOT NUMBER WAS 64101501, WITH AN EXPIRATION DATE OF 31-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770518 ↗
• MalfunctionMar 23, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDE RESULTS FROM COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER REPEATED PATIENT SAMPLES BECAUSE THEY HAVE A PROCEDURE TO RETEST SAMPLES IF THE QC PERFORMED AFTERWARD WAS OUT OF RANGE. ONE EXAMPLE WAS AN INITIAL RESULT OF 273 MG/DL AND A REPEAT RESULT OF 392 MG/DL. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862136 ↗

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.