Cholesterol Gen.2 3039773190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630918430), received between Feb 2, 2023 and Sep 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K031824); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Non Reproducible Results

  We received an allegation about discrepant results for 1 patient sample tested with Cholesterol Gen.2 assay on a cobas 4000 c311 stand alone system.Initial result: 418.4 mg/dL.The customer noticed that the initial result was high. No questionable result was reported outside the laboratory, and the sample was repeated.Repeat result: 218.5 mg/dL.The repeat result was deemed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870258 ↗
• 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 CHOLESTEROL 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 LDL 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: (B)(6). REPEAT RESULTS: (B)(6) REPEAT RESULTS AFTER A 1:10 MANUAL DILUTION: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756819 ↗
• MalfunctionNov 25, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS INTEGRA 400 PLUS W/O ISE. ON (B)(6) 2025: THE INITIAL RESULT WAS 383 MG/DL. THE FIRST REPEAT RESULT WAS 186 MG/DL. THE SECOND REPEAT RESULT WAS 188 MG/DL. ON (B)(6) 2025: THE INITIAL RESULT WAS 350 MG/DL. THE FIRST REPEAT RESULT WAS 182 MG/DL. THIS RESULT WAS DEEMED CORRECT AND REPORTED. THE SECOND REPEAT RESULT WAS 183 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644704 ↗
• MalfunctionAug 14, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS MODULE. ON (B)(6) 2025, THE INITIAL CHOLESTEROL RESULT WAS 443.08 MG/DL. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. ON (B)(6) 2025, THE SAMPLE WAS REPEATED AND THE RESULT WAS 233.45 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806820 ↗
• MalfunctionJun 25, 2025Material Integrity Problem; Material Integrity Problem

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CHOLESTEROL GEN.2 (CHOL2) ON A COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 15.49 MMOL/L. ON 02-JUN-2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 5.44 MMOL/L. THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 5.72 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326945 ↗
• MalfunctionJan 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem; Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FROM THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 445.49 MG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 241.21 MG/DL WITH A DATA FLAG. THIS RESULT WAS BELIEVED TO BE CORRECT. THE CHOLESTEROL RESULT FROM A SECOND SAMPLE FROM THE PATIENT ON THE SAME DAY WAS 245.83 MG/DL WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273162 ↗
• MalfunctionJul 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH CHOLESTEROL GEN.2 ON A COBAS 6000 C501 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 5.5 MG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 211.3 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 213.6 MG/DL WITH A DATA FLAG. THE SECOND SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 4.7 MG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 192.5 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 192.5 MG/DL WITH A DATA FLAG. THE THIRD SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 5.6 MG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 163.0 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 167.1 MG/DL WITH A DATA FLAG. THE FOURTH SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 5.0 MG/DL. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 233.3 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 229.2 MG/DL WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793186 ↗
• MalfunctionMay 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FROM THE COBAS INTEGRA 400 PLUS. THE SAMPLES WERE REPEATED AT THE SAME LABORATORY AND THEN AT ANOTHER LABORATORY. SAMPLE 1 INITIAL RESULT WAS 0.37 MMOL/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 3.21 MMOL/L AND 6.40 MMOL/L. SAMPLE 2 INITIAL RESULT WAS 0.01 MMOL/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 3.21 MMOL/L AND 4.60 MMOL/L. SAMPLE 3 INITIAL RESULT WAS 9.23 MMOL/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 5.20 MMOL/L AND 4.86 MMOL/L. SAMPLE 4 INITIAL RESULT WAS 15.73 MMOL/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 5.20 MMOL/L AND 6.56 MMOL/L. SAMPLE 5 INITIAL RESULT WAS 11.26 MMOL/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 5.20 MMOL/L AND 4.61 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350570 ↗
• MalfunctionFeb 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH CHOL HICO GEN.2 (CHOL2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. INITIAL RESULT: 615.10 MG/DL (ACCOMPANIED BY A DATA FLAG). THE PATIENT QUESTIONED THE RESULT AND ON (B)(6) 2024 THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 179.13 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739343 ↗
• MalfunctionFeb 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOL2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS MODULE. THE INITIAL RESULT WAS 527.92 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. ON (B)(6) 2024 THE SAMPLE WAS REPEATED AND THE RESULT WAS 263.83 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670733 ↗
• MalfunctionFeb 2, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOL2 CHOLESTEROL GEN.2 RESULTS FROM 1 PATIENT ON A COBAS 6000 C501 MODULE. THE CUSTOMER SUSPECTS THAT THERE IS AN INTERFERING FACTOR IN THE PATIENT SAMPLE. ON (B)(6) 2023, THE CUSTOMER INITIALLY RECEIVED A CHOLESTEROL RESULT OF 913 MG/DL WITH A FLAG INDICATING THAT THE VALUE WAS ABOVE THE MEASURING RANGE OF THE ASSAY. AFTER AUTOMATIC DILUTION, THE RESULT WAS 892 MG/DL. A 1:20 MANUAL DILUTION WAS PERFORMED AND THE RESULT WAS AROUND 1000 MG/DL. ON (B)(6) 2023, ANOTHER SAMPLE WAS COLLECTED AND IT GAVE A CHOLESTEROL RESULT OF 941 MG/DL WITH A FLAG INDICATING THAT THE VALUE WAS ABOVE THE MEASURING RANGE OF THE ASSAY. AFTER AUTOMATIC DILUTION, THE RESULT WAS 996 MG/DL. A 1:20 MANUAL DILUTION WAS PERFORMED AND THE RESULT WAS AROUND 1000 MG/DL. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287066 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031824. One submission often covers many models, so check the product and lot details in each record.

• Z-1921-2015 · May 7, 2015 · Terminated
  Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems,