HDL-Cholesterol Gen.4 07528582190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630942572), received between Nov 30, 2022 and Nov 7, 2024 — 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.

• MalfunctionNov 7, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 8000 C702 MODULE. ON (B)(6) 2024, THE INITIAL HDL RESULT WAS 149 MG/DL. ON (B)(6) 2024, THE SAMPLE WAS REPEATED AND THE RESULT WAS 50.2 MG/DL. A 1:2 DILUTION WAS MADE OF THE SAMPLE AND REPEATED AND THE RESULT WAS 51.4 MG/DL. A 1:5 DILUTION WAS MADE OF THE SAMPLE AND REPEATED AND THE RESULT WAS 53 MG/DL. THE REPEAT RESULTS WERE DEEMED MORE CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633687 ↗
• MalfunctionDec 20, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 110 PATIENT SAMPLES TESTED FOR HDLC4 ON A COBAS 8000 C 702 MODULE. DUE TO THE LOW RESULTS, THE CUSTOMER REPEATED THE PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 4 PATIENT SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL RESULT WAS 28 MG/DL. THE REPEAT RESULT WAS 51 MG/DL. PATIENT 2 INITIAL RESULT WAS 30 MG/DL. THE REPEAT RESULT WAS 53 MG/DL. PATIENT 3 INITIAL RESULT WAS 26 MG/DL. THE REPEAT RESULT WAS 54 MG/DL. PATIENT 4 INITIAL RESULT WAS 22 MG/DL. THE REPEAT RESULT WAS 46 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367266 ↗
• MalfunctionOct 5, 2023High Test Results; Output Problem; High Test Results; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE HDLC4 RESULTS FROM THE COBAS 8000 C702 MODULE. THE FIRST RESULT WAS 113.7 MG/DL AND THE REPEAT RESULTS ON ANOTHER SYSTEM WERE 37.7 MG/DL AND 37.8 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875853 ↗
• 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 HDLC4 ASSAY. PLEASE REFER TO MDR WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE LDLC3 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 16800432 ↗
• MalfunctionJan 13, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION (LDL_C) ON A COBAS 8000 C 702 MODULE COMPARED TO A NON-ROCHE METHOD. OF THE DATA PROVIDED, DISCREPANT RESULTS FOR HDL-CHOLESTEROL GEN.4 (HDLC4) WERE IDENTIFIED. THIS MEDWATCH WILL COVER HDLC4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDL_C RESULTS. THE LDL_C RESULT FROM THE C702 MODULE WAS 97.6 MG/DL THE LDL CHOLESTEROL RESULT FROM THE NON-ROCHE METHOD WAS 316.0 MG/DL. THE HDLC4 CHOLESTEROL RESULT FROM THE C702 MODULE WAS 50.1 MG/DL. THE HDL CHOLESTEROL RESULT FROM THE NON-ROCHE METHOD WAS 27.9 MG/DL. THE CUSTOMER MENTIONED THE PRODUCT LABELING LISTS AN INTERFERENCE STATEMENT RELATED TO ASCORBIC ACID. IT WAS ASKED BUT IT IS NOT KNOWN IF THE PATIENT IS TAKING ASCORBIC ACID. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C702 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156439 ↗
• 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 HDL3C. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDL_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887847 ↗