HDL-Cholesterol Gen.4 08057877190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336121306), received between Jan 12, 2024 and Jul 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HDL-CHOLESTEROL GEN.4 RESULTS FOR 1 PATIENT ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 15.5 MG/DL. THE RESULT WAS CONSIDERED TO BE TOO LOW AND THE SAMPLE WAS REPEATED. ON (B)(6) 2025, THE REPEATED RESULT WAS 14.8 MG/DL. BOTH VALUES WERE QUESTIONED AS THE PATIENT'S EXPECTED RESULT WAS 30 MG/DL. THE SAMPLE WAS SENT TO ANOTHER LABORATORY (METHOD UNKNOWN) TO BE TESTED, AND THE RESULT WAS 25 MG/DL. THE PATIENT'S CHOLESTEROL RESULT WAS 156 MG/DL, THE LDL RESULT WAS 94.0 MG/DL, AND THE TRIGLYCERIDE RESULT WAS 225 MG/DL. THE PHYSICIAN DID NOT AGREE WITH THE HDL RESULTS BASED ON THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383432 ↗
• MalfunctionJun 2, 2025Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR HDL-CHOLESTEROL GEN.4 (HDLC4) ASSAY ON A COBAS C503 ANALYTICAL UNIT. INITIAL RESULT: 3.35 MG/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. REPEAT RESULT: 92.80 MGDL. THE REPEAT RESULT OF 92.8 MGDL WAS DEEMED TO BE CORRECT. NO QUESTIONABLE RESULT WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124149 ↗
• MalfunctionFeb 19, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HDL- CHOLESTEROL GEN.4 (HDLC4) ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS 218 MG/DL. THE REPEAT RESULT WAS 64 MG/DL. SAMPLE 2: THE INITIAL RESULT WAS 104 MG/DL. THE REPEAT RESULT WAS 42 MG/DL. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY BECAUSE THEY WERE DEEMED HIGH AND INCONSISTENT WITH PATIENTS' HISTORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409818 ↗
• MalfunctionJan 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE HDL-CHOLESTEROL GEN.4 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.18 MMOL/L. THE CUSTOMER CONSIDERED THE RESULT TO BE UNACCEPTABLY HIGH AND REPEATED THE SAMPLE. ON (B)(6) 2024 THE REPEATED RESULT WAS 1.64 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21082972 ↗
• MalfunctionJan 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL HDLC4 RESULT WAS 38.2 MG/DL AND THE REPEAT RESULT WAS 76.9 MG/DL. THE INITIAL CHOLESTEROL RESULT WAS 283 MG/DL AND THE REPEAT RESULT WAS 161 MG/DL. THE INITIAL TRIGLYCERIDE RESULT WAS 249 MG/DL AND THE REPEAT RESULT WAS 58.1 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508642 ↗