LDL-Cholesterol Gen.3 07005717190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630934584), received between Apr 28, 2022 and Apr 1, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low 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 LDL 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 HDL 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 24756826 ↗
• MalfunctionNov 25, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LDL-CHOLESTEROL GEN.3 ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 502 MODULE. ON (B)(6) 2025: THE INITIAL RESULT WAS 102.7 MG/DL. ON (B)(6) 2025: THE REPEAT RESULT WAS 166.8 MG/DL. THIS RESULT WAS CONSISTENT WITH THE PATIENT'S PREVIOUS FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643890 ↗
• MalfunctionAug 14, 2025Chemical Problem; Non Reproducible Results; Chemical Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LDL-CHOLESTEROL GEN.3 RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 502 MODULE WHEN COMPARED TO THE BECKMAN COULTER AU5800 MODULE. THE INITIAL RESULT ON THE C 502 WAS 0.95 MMOL/L. THE REPEAT RESULT ON THE AU5800 WAS 2.92 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805848 ↗
• MalfunctionOct 2, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH LOW DENSITY LIPOPROTEINS-CHOLESTEROL GEN.3 (LDL3) ASSAY AND 1 PATIENT'S SAMPLE TESTED WITH TRIGYLCERIDES (TRIGL) ASSAY ON A COBAS 6000 C501 ANALYZER. SAMPLE 1 WAS TESTED FOR LDL3 (PATIENT 1): INITIAL RESULT: 54 MG/DL. RERUN RESULT: 137.7 MG/DL. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AS THE RESULT DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS THEN REPEATED AND THE REPEAT RESULT WAS DEEMED TO BE CORRECT. SAMPLE 2 WAS TESTED FOR TRIGL (PATIENT 2): INITIAL RESULT: 366.9 MG/DL. 1ST REPEAT RESULT: 265.5 MG/DL. 2ND REPEAT RESULT: 266 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850833 ↗
• MalfunctionApr 28, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE LDL-CHOLESTEROL PLUS 2ND GENERATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C 501 (UL) V MODULE, SERIAL NUMBER (B)(4). THE DIRECT LDL RESULT WAS 204.2 MG/DL AND THE TOTAL CHOLESTEROL RESULT WAS 131 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT DUE TO THE RESULTS NOT MEETING THE CLINICAL PICTURE OF THE PATIENT. THE PATIENT'S DOCTOR MANUALLY CALCULATED THE LDL USING THE FRIEDEWALD FORMULA AND THE CALCULATED LDL RESULT WAS 58 MG/DL. THIS RESULT WAS CONSIDERED TO BE CORRECT. THE SAMPLE TESTS WERE REPEATED ON (B)(6) 2022 AND SIMILAR RESULTS WERE OBSERVED. NUMERICAL RESULT VALUES FOR THE REPEATED RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14236534 ↗