TriglyceridesRecalls & reported problems across all models

We found 4 models of Triglycerides by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2018 and Sep 30, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Triglycerides problems

Triglycerides models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Triglycerides 08058687190

  LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
  21 reports
• Triglycerides 20767107322

  LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
  13 reports
• Triglycerides 05171407190

  LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
  11 reports
• Triglycerides 04657594190

  LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
  1 report

Recent Triglycerides adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 1, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539341 ↗
• MalfunctionAug 5, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139372 ↗
• MalfunctionMay 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGLYCERIDES (TRIGL) ASSAY RESULTS FROM ONE PATIENT'S SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 151 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 318 MG/DL WITH AN INVALIDATING DATA FLAG. THE SECOND REPEAT RESULT USING THE DECREASED MODE WAS 3661 MG/DL. THIS RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203750 ↗
• MalfunctionMay 1, 2026High Test Results; Ambient Temperature Problem

  THE INITIAL REPORTER ALLEGED ABNORMALLY ELEVATED TRIGLYCERIDES ASSAY RESULTS FROM APPROXIMATELY 100 PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. ONE EXAMPLE OF THE ALLEGED ABNORMALLY ELEVATED ASSAY RESULT WAS PROVIDED: ON (B)(6) 2026: THE CUSTOMER HAD AN AIR CONDITIONING MALFUNCTION. THE ANALYZER WAS LOCATED NEAR AN OPEN WINDOW. THE PATIENT'S INITIAL RESULT WAS 7.32 MMOL/L. ON (B)(6) 2026: THE QCS WERE OUT OF RANGE (HIGH). THE CUSTOMER REPLACED THE REAGENT PACK AND RERAN THE QCS AND PATIENT SAMPLES; THE REPEAT QCS WERE WITHIN THE SPECIFIED RANGES. THE REPEAT RESULT WAS 1.41 MMOL/L. THIS RESULT WAS DEEMED NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055797 ↗
• MalfunctionApr 1, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TRIGLYCERIDES ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 456 MG/DL. THE REPEAT RESULT WAS 97.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758025 ↗
• 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 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TRIGLYCERIDES ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 682 MG/DL. THE SAMPLE WAS DILUTED 1:5 WITH NACL AND REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF > 5375 MG/DL WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 WITH NACL AND REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF 5638 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF > 950 MG/DL WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN A TRIGLYCERIDES VALUE OF 5682 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739699 ↗
• MalfunctionMar 30, 2026Prophylactic removal due to corrective action

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TRIGLYCERIDES ON A COBAS 8000 C702 MODULE. THE CUSTOMER STATED THE SAMPLE WAS LIPEMIC. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 2.22 MMOL/L. THE VALUE DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, SO IT WAS REPEATED. THE SAMPLE WAS REPEATED USING DECREASED SAMPLE VOLUME AFTER ULTRACENTRIFUGATION OF THE SAMPLE AND IT RESULTED IN A VALUE OF 11.62 MMOL/L ACCOMPANIED BY A FLAG INDICATING THERE WERE ISSUES WITH THE REACTION KINETICS. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN A VALUE OF 39.03 MMOL/L. A REPEAT VALUE OF 30.03 MMOL/L AFTER 1:20 DILUTION WAS ALSO PROVIDED, BUT IT IS NOT KNOWN IF THIS IS AN ACTUAL REPEAT VALUE OR IF IT WAS PROVIDED IN ERROR. THE CUSTOMER IS QUESTIONING WHY THE INITIAL VALUE OF 2.22 MMOL/L WAS NOT ACCOMPANIED BY A FLAG INDICATING AN ISSUE WITH REACTION KINETICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731006 ↗
• MalfunctionFeb 4, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TRIGLYCERIDES ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 232 MG/DL AND IT REPEATED AS 112 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 234 MG/DL ON (B)(6) 2026 AND IT REPEATED AS 92.1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260453 ↗
• MalfunctionJan 27, 2026Low Test Results; Output Problem

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TRIGLYCERIDES ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 1.74 MMOL/L. THE REPEAT RESULT AFTER THE SAMPLE WAS DILUTED 1:50 WAS 88.99 MMOL/L. THE REPEAT RESULT AFTER ULTRACENTRIFUGATION WAS 15.07 (ACCOMPANIED BY AN INVALIDATING DATA FLAG).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192165 ↗
• MalfunctionJan 21, 2026Incorrect Measurement

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TRIGLYCERIDE RESULT FROM ONE PATIENT'S SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 2.17 MMOL/L. THE FIRST REPEAT RESULT WAS 1.91 MMOL/L. THE SECOND REPEAT RESULT AT 1:10 DILUTION WAS 51.55 MMOL/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131046 ↗
• MalfunctionDec 5, 2025Device Difficult to Setup or Prepare; Low Test Results; Device Difficult to Setup or Prepare; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 1.25 MMOL/L, AND THE REPEATED RESULT WAS 1.31MMOL/L. THE SAMPLE WAS REPEATED WITH A DILUTION (1:10), AND THE RESULT WAS 49.76 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE RESULTS DIDN'T MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730117 ↗
• MalfunctionNov 14, 2025High Test Results; Material Integrity Problem; High Test Results; Material Integrity Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS IT DID NOT MATCH THE PATIENTS' PREVIOUS RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLES. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF 388 MG/DL. THE SAMPLE WAS REPEATED AND THE RESULT WAS 155 MG/DL. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER C503 ANALYZER AND THE RESULT WAS 157 MG/DL. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF 212 MG/DL. THE SAMPLE WAS REPEATED TWICE AND THE RESULT WAS 114 MG/DL AND 115 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556767 ↗
• 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 ↗

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