HDL-Cholesterol Gen.4 07528566190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630942565), received between Mar 14, 2022 and Apr 1, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 18, 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.

• 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 HDL 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 TRIGLYCERIDES 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 24756818 ↗
• MalfunctionNov 11, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR SEVERAL PATIENT SAMPLES TESTED WITH THE HDL-CHOLESTEROL GEN.4 ASSAY ON A COBAS 6000 C501 MODULE. THE REPORTER STATED THAT THE ASSAY RESULTS HAVE BEEN HIGHER THAN NORMAL AND WERE REPEATABLE ON THE SAME INSTRUMENT. THEY NOTED DISCREPANCIES WHEN THE RESULTS WERE COMPARED WITH THE PATIENTS' HISTORICAL DATA. ONE EXAMPLE OF A QUESTIONABLE RESULT WAS PROVIDED: THE INITIAL RESULT WAS 70 MG/DL. THIS RESULT DID NOT MATCH THE PATIENT'S HISTORICAL DATA OF 40 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525834 ↗
• MalfunctionOct 17, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HDLC4 HDL-CHOLESTEROL PLUS 4TH GENERATION (HDL) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 115 MG/DL. THE REPEAT RESULT WAS 36 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951424 ↗
• MalfunctionJul 6, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CA2 (CALCIUM GEN.2) ASSAY ON A COBAS 8000 COBAS C 502 MODULE. THE SAMPLE INITIALLY RESULTED IN A CA2 VALUE OF 1.269 MMOL/L. A SECOND SAMPLE COLLECTED FROM THE SAME PATIENT WAS TESTED, RESULTING IN A CA2 VALUE OF 2.353 MMOL/L. THE INITIAL SAMPLE WAS THEN REPEATED ON THE SAME AND A SECOND MODULE, RESULTING IN CA2 VALUES OF 2.97 MMOL/L AND 2.254 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265638 ↗
• MalfunctionMar 14, 2022Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HDLC4 HDL-CHOLESTEROL PLUS 4TH GENERATION RESULTS FOR MULTIPLE PATIENT SAMPLES WITH A COBAS 6000 C501 MODULE. THE REPORTER STATED THEY WERE RECEIVING VERY LOW RESULTS BUT MOST WERE WITH DATA FLAGS. THEY REPLACED THE REAGENT PACK, CALIBRATION AND QC WERE ACCEPTABLE AND HAD NO FURTHER ISSUES. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 7 PATIENT SAMPLES THAT DID NOT HAVE DATA FLAGS: SAMPLE 1: THE INITIAL RESULT WAS 7 MG/DL. THE REPEATED RESULT WAS 37 MG/DL. SAMPLE 2: THE INITIAL RESULT WAS 3 MG/DL. THE REPEATED RESULT WAS 8 MG/DL. THE SECOND REPEATED RESULT WAS 61 MG/DL. SAMPLE 3: THE INITIAL RESULT WAS 3 MG/DL. THE REPEATED RESULT WAS 40 MG/DL. SAMPLE 4: THE INITIAL RESULT WAS 5 MG/DL. THE REPEATED RESULT WAS 45 MG/DL. SAMPLE 5: THE INITIAL RESULT WAS 8 MG/DL. THE REPEATED RESULT WAS 59 MG/DL. SAMPLE 6: THE INITIAL RESULT WAS 7 MG/DL. THE REPEATED RESULT WAS 43 MG/DL. SAMPLE 7: THE INITIAL RESULT WAS 6 MG/DL. THE REPEATED RESULT WAS 42 MG/DL. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE COBAS C501 SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756453 ↗