Triglycerides 05171407190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630925117), received between Apr 25, 2019 and May 1, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 19, 2025Calibration Problem; Calibration Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES/GB (GLYCEROL BLANKED) RESULTS FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 0.01 MMOL/L. THE REPEAT RESULT USING A REDUCED SAMPLE VOLUME WAS 0.02 MMOL/L. ON (B)(6) 2025, THE REPEAT RESULT WAS 0.76 MMOL/L. USING ANOTHER SAMPLE FROM THE PATIENT, THE RESULT WAS 2.34 MMOL/L. IT WAS UNCLEAR IF THIS SAMPLE WAS FROM THE SAME VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097854 ↗
• MalfunctionSep 12, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TRIGLYCERIDES RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THE CUSTOMER QUESTIONED THE HIGH INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS AND THE CHOLESTEROL AND GLUCOSE RESULTS, WHICH PROMPTED THEM TO REPEAT THE SAMPLES. SAMPLE 1 HAD AN INITIAL RESULT OF 213 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C 702 ANALYZER AND THE RESULT WAS 148 MG/DL. SAMPLE 2 HAD AN INITIAL RESULT OF 305 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C 702 ANALYZER AND THE RESULT WAS 168 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037276 ↗
• MalfunctionFeb 26, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGL TRIGLYCERIDES AND CHOL2 CHOLESTEROL GEN.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THIS MDR IS FOR THE TRIGL ASSAY. PLEASE REFER TO MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE CHOL2 ASSAY. THE REPORTED COMPLAINED THAT THE PATIENT SAMPLE HAD CHOL2 AND TRIGL RESULTS CLOSE TO ZERO BUT THE HDL-C AND LDL-C TOTALED TO OVER 100 MG/DL (HDL = 52 MG/DL; LDL = 53 MG/DL). THE PHYSICIAN DID NOT BELIEVE THE RESULTS BECAUSE THEY COULD NOT BE CORRECT AND WERE INCOMPATIBLE WITH LIFE. THE REPORTER STATED THAT THERE IS AN INTERFERENCE DUE TO THE THERAPY OF PARACETAMOL INTOXICATION INDICATED IN THE FOUR ASSAYS MENTIONED AND ALSO ANOTHER INTERFERENCE FOR THE CHOL2 AND TRIGL ASSAYS. ON (B)(6) 2024: THE INITIAL TRIGL RESULT WAS <5 MG/DL. THE FIRST REPEAT RESULT WAS <5 MG/DL. ON (B)(6) 2024: THE SECOND REPEAT RESULT WAS <5 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776406 ↗
• MalfunctionAug 22, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TRIGL TRIGLYCERIDES ON A COBAS 8000 C (701) MODULE. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 391 MG/DL AND THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE DOCTOR COMPLAINED ABOUT THE VALUE SINCE IT DID NOT FIT WITH VALUES FROM OTHER LIPID TESTS. THE SAMPLE WAS REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF 133.5 MG/DL. AS THIS VALUE ALSO DID FIT WITH OTHER VALUES, THE SAMPLE WAS REPEATED AGAIN. THE SAMPLE WAS REPEATED A SECOND TIME ON (B)(6) 2022, RESULTING IN A VALUE OF 965.8 MG/DL ACCOMPANIED BY A >KIN DATA FLAG, INDICATING UNSTABLE REACTION KINETICS. THE SAMPLE WAS AUTOMATICALLY REPEATED AT DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 4180.4 MG/DL. THE SAMPLE WAS REPEATED A THIRD TIME ON (B)(6) 2022, RESULTING IN A VALUE OF 1302.9 MG/DL ACCOMPANIED BY A > ABS DATA FLAG, INDICATING HIGH ABSORBANCE. THE SAMPLE WAS AUTOMATICALLY REPEATED AT DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 4138.9 MG/DL. AS THE VALUES WERE ABNORMAL, THE CUSTOMER RE-CENTRIFUGED THE SAMPLE AT A HIGHER SPEED AND REPEATED THE SAMPLE A FOURTH TIME ON (B)(6) 2022, RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266885 ↗
• MalfunctionMar 23, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THAT 4 SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH TRIGL TRIGLYCERIDES ON A COBAS 8000 C (701) MODULE. THE SPECIFIC DATE THE EVENT OCCURRED WAS REQUESTED, BUT NOT PROVIDED. THE CUSTOMER STATED THAT TRIGLYCERIDE MEASUREMENTS OF THE 4 SAMPLES YIELDED HIGH RESULTS OF > 1000 MG/DL. THE MEASUREMENTS WERE NOT CONSIDERED PLAUSIBLE BY THE CUSTOMER AS THEY DID NOT AGREE WITH OTHER DIAGNOSTIC FINDINGS OF THE PATIENT. THE RESULTS FROM THREE OF THE FOUR SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY WITH A COMMENT STATING THE RESULTS WERE NOT PLAUSIBLE. THE SERIAL NUMBER OF THE C 701 ANALYZER IS 17J2-08.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869625 ↗
• MalfunctionApr 25, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. NON-REPRODUCIBLE RESULTS WERE GENERATED BY THE COBAS 8000 C 702 MODULE FOR TRIGL TRIGLYCERIDES. THE EVENT INVOLVED A TOTAL OF 1 PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549721 ↗

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.