LDL-Cholesterol Gen.3 07005768190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630934591), received between Nov 2, 2022 and Feb 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (4 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH LDL-CHOLESTEROL GEN.3 (LDLC3) ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 0.4 MG/DL. THE CUSTOMER NOTICED THAT THE INITIAL RESULT WAS <3.8 MG/DL AND IT WAS AUTO-VALIDATED BY THE INFINITY. REPEAT RESULT: 155.6 MG/DL. REPORTEDLY, THE REPEAT RESULT WAS AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433245 ↗
• MalfunctionFeb 4, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH LDL-CHOLESTEROL GEN.3 (LDLC3) ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 2.32 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 6.03 MMOL/L (TESTED ON HITACHI WAKO). THE REPEAT RESULT WAS CONSISTENT WITH THE LDL CALCULATION METHOD (FRIEDEWALD). THE CUSTOMER SUSPECTED AN INTERFERENCE OF LIPOPROTEIN X OR LP(X).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306656 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LDL-CHOLESTEROL GEN.3 (LDLC3) RESULTS FROM ONE PATIENT SAMPLE TESTED ON AN UNSPECIFIED NUMBER OF COBAS 8000 C702 MODULES. THE INITIAL RESULT FROM THE MODULE WAS 1.92 MMOL/L. THE REPEAT RESULT FROM A NON-ROCHE REAGENT AND PLATFORM WAS 9.32 MMOL/L. THE REPORTER STATED THAT THE PATIENT'S LDLC3 WAS RETESTED IN C702 MODULES IN OTHER FACILITIES AND THE RESULTS WERE CONSISTENT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT DID NOT MEET THE CLINICAL DIAGNOSIS AND THEY ARE CONSIDERING LIPOPROTEIN X (LP-X) INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114657 ↗
• MalfunctionApr 24, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HDLC3 HDL-CHOLESTEROL PLUS 4TH GENERATION AND LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 8000 C702 MODULE WITH SERIAL NUMBER (B)(6) . THIS MDR IS FOR THE LDLC3 ASSAY. PLEASE REFER TO MDR WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE HDLC4 ASSAY. SAMPLE 1 THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT ALIGN WITH THE PATIENT'S CLINICAL PICTURE. THE REPORTER ALSO STATED THAT THE HDLC4 AND LDLC3 RESULTS DID NOT AGREE WITH THE ELEVATED CHOLESTEROL AND TRIGLYCERIDE RESULTS. THE REPORTER STATED THAT THEY DID NOT PERFORM ANY RERUNS FOR THE PATIENT SAMPLE. ON (B)(6) 2023, THE HDLC4 RESULT WAS 0.05 MMOL/L AND THE LDLC3 RESULT WAS 0.36 MMOL/L. THE REPORTER THEN CHECKED THE REACTION MONITORS AND NOTED THE ABSORBANCE WAS ALREADY HIGH AT THE START OF THE REACTION OF THE QUESTIONABLE RESULTS. THE REPORTER WAS ALSO CONCERNED THAT QUESTIONABLE RESULTS WERE NOT FLAGGED AND NO ALARMS WERE RECEIVED FROM THE MODULE. THE REPORTER STATED THAT THE SAMPLE WAS LIPEMIC AND HEMOLYTIC WITH THE FOLLOWING INDICES: LIPEMIA = 552; ICTERUS = 2; HEMOLYSIS = 135. SAMPLE 2 ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16800426 ↗
• MalfunctionNov 30, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT HDLC3 HDL-CHOLESTEROL PLUS 4TH GENERATION AND LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE COMPARED TO A BECKMAN ANALYZER. THE HDL RESULT FROM THE ROCHE ANALYZER WAS 0.26 MMOL/L. THE HDL RESULT FROM THE BECKMAN ANALYZER WAS 1.39 MMOL/L THE ROCHE HDL REFERENCE RANGE IS 1.31 - 3.29 MMOL/L. THE BECKMAN HDL REFERENCE RANGE IS 1.03 - 1.55 MMOL/L. THE LDL RESULT FROM THE ROCHE ANALYZER WAS 4.72 MMOL/L. THE LDL RESULT FROM THE BECKMAN ANALYZER WAS 21.92 MMOL/L. THE ROCHE LDL REFERENCE RANGE IS 1.31 - 3.29 MMOL/L. THE BECKMAN LDL REFERENCE RANGE IS 1.89 - 4.21 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C702 ANALYZER SERIAL NUMBER IS (B)(4). THIS MEDWATCH WILL COVER LDL_C. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HDLC3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887875 ↗
• MalfunctionNov 2, 2022Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION ON A COBAS 8000 C 702 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY TESTED ON THE C 702 ANALYZER, RESULTING IN AN LDL VALUE OF 3.5 MMOL/L. THE SAMPLE WAS REPEATED ON A HITACHI 7600 COMPETITOR SYSTEM, RESULTING IN AN LDL VALUE OF 17.38 MMOL/L. THE SERIAL NUMBER OF THE C 702 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715739 ↗