LDL-Cholesterol Gen.3 08057966190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336121375), received between Oct 24, 2023 and Sep 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 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.

• MalfunctionSep 28, 2026Non Reproducible Results

  There was an allegation of questionable LDL-Cholesterol Gen.3 results from the cobas c 503 analytical unit. One example was provided of an initial result of 11.3 mg/dL, and a repeat result of 122 mg/dL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914631 ↗
• MalfunctionNov 26, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE LDL-CHOLESTEROL GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. ON (B)(6) 2025: THE INITIAL RESULT FROM THE MODULE WAS 1.39 MMOL/L. THE REPEAT RESULT AT 1:2 DILUTION WAS 0.956 MMOL/L WITH A FINAL CALCULATED DILUTION RESULT OF 1.912 MMOL/L. THE REPEAT RESULT AT 1:10 DILUTION WAS 0.173 MMOL/L WITH A FINAL CALCULATED DILUTION RESULT OF 1.73 MMOL/L. ON (B)(6) 2025: THE REPEAT RESULT FROM THE MODULE WAS 1.96 MMOL/L. ON (B)(6) 2025: THE REPEAT RESULT FROM AN ARCHITECT ANALYZER WAS 4.44 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655738 ↗
• MalfunctionOct 29, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDL-CHOLESTEROL GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN LDL VALUE OF 5.00 MMOL/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED, RESULTING IN AN LDL VALUE OF 5.10 MMOL/L WITH A DATA FLAG. THESE VALUES WERE HELD AND NOT RELEASED TO THE PATIENT. THE SAMPLE WAS REPEATED AGAIN, RESULTING IN AN LDL VALUE OF 1.49 MMOL/L WHICH WAS THEN RELEASED TO THE PATIENT. THE SAMPLE WAS REPEATED AFTERWARDS AND RESULTED IN A VALUE OF 5.07 MMOL/L WITH A DATA FLAG. AN AMENDED REPORT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416805 ↗
• MalfunctionNov 26, 2024Chemical Problem; Non Reproducible Results; Chemical Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LDLC3- (LOW DENSITY, LIPOPROTEIN) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 26 MG/DL. THE SAME SAMPLE WAS REPEATED ON ANOTHER PRO ANALYZER WITH A RESULT OF 27 MG/DL AND ON A C311 ANALYZER WITH A RESULT OF 22 MG/DL. THE SAME SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER AND THE RESULT WAS 87 MG/DL. PATIENT 2: ((B)(6) 2024): THE INITIAL RESULT WAS 10 MG/DL. THE SAME SAMPLE WAS REPEATED ON ANOTHER PRO ANALYZER WITH A RESULT OF 11 MG/DL. THE SAME SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER AND THE RESULT WAS 119 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783786 ↗
• MalfunctionOct 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LDLC3 ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 19.4 MG/DL. THE SAMPLE WAS REPEATED DUE TO A REQUEST FROM THE CLINICIAN. THE REPEAT RESULT WAS 127 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998131 ↗