Cholesterol 08057443190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613336121115), received between Jan 5, 2023 and Sep 18, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Incorrect Measurement

  There was an allegation of questionable Cholesterol Gen.2 results from the cobas c 503 analytical unit.The initial result was 3.41 mg/dl, and the repeat result was 295 mg/dl.The questionable result was not reported outside of the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821000 ↗
• MalfunctionAug 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50140617 ↗
• MalfunctionAug 3, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114300 ↗
• MalfunctionApr 16, 2026Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED WITH CHOLESTEROL GEN.2 ASSAY ON A COBAS C 303 ANALYTICAL UNIT. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED: INITIAL RESULT: 7.00 MMOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT CORRELATE WITH THE PATIENT'S LDL AND HDL RESULTS, AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 3.5 MMO/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893538 ↗
• MalfunctionFeb 17, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FOR 10 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. REFER TO THE ATTACHMENT "(B)(4)" FOR PATIENT RESULTS. THE UNITS OF MEASURE WERE NOT PROVIDED. THE PHYSICIAN QUESTIONED THE CHOLESTEROL RESULTS BECAUSE THE RESULTS DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS. THE SUM OF THE HDL AND LDL RESULTS WAS GREATER THAN THE CHOLESTEROL GEN.2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362372 ↗
• MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 269 MG/DL. THE REPEATED RESULTS WERE 167.69 MG/DL AND 162.30 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320555 ↗
• MalfunctionJan 6, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ON A COBAS C 703 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 6.56 MG/DL. THE CUSTOMER REQUESTED A REPEAT OF THE SAMPLE SINCE THE VALUE WAS LOWER THAN EXPECTED. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 179 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979933 ↗
• MalfunctionJan 5, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 445 MG/DL AND IT REPEATED AS 210 MG/DL. THE SAMPLE WAS REPEATED 5 ADDITIONAL TIMES ON A SECOND ANALYZER, RESULTING IN THE FOLLOWING VALUES: 209 MG/DL, 211 MG/DL, 210 MG/DL, 209 MG/DL, 210 MG/DL, THE SAMPLE WAS ALSO REPEATED 5 ADDITIONAL TIMES ON THE ORIGINAL ANALYZER, RESULTING IN THE FOLLOWING VALUES: 211 MG/DL, 211 MG/DL, 211 MG/DL, 210 MG/DL, AND 211 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956775 ↗
• MalfunctionDec 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CHOLESTEROL GEN.2 (CHOL2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.59 MG/DL. THE REPEAT RESULT WAS 201 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860438 ↗
• MalfunctionNov 10, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CHOLESTEROL GEN.2 RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 439 MG/DL, AND THE REPEAT RESULT WAS 163 MG/DL. THE SAMPLE WAS TESTED IN A REFERENCE LAB AND HAD A RESULT OF 163 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512181 ↗
• MalfunctionNov 6, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE ATTENDING PHYSICIAN COMPLAINED THAT THE TOTAL CHOLESTEROL RESULT WAS IMPLAUSIBLY HIGH AND DID NOT CORRELATE WITH THE OTHER RESULTS FOR THE PATIENT. IT WAS SUSPECTED THERE WAS AN INTERFERENCE WITH THE PATIENT'S MEDICATION SEEBRI (GLYCOPYRRONIUM AS GLYCOPYRRONIUM BROMIDE) FOR INHALATION. REPEAT MEASUREMENTS FROM THIS SAMPLE AND A SECOND SAMPLE FROM THE PATIENT SHOWED THE SAME CONSTELLATION. NO SPECIFIC DATA COULD BE PROVIDED. THE TOTAL CHOLESTEROL RESULT WAS 6.8 MMOL/L. THE PATIENT'S HDL CHOLESTEROL RESULT WAS 0.32 MMOL/L, LDL CHOLESTEROL RESULT WAS 1.02 MMOL/L, AND TRIGLYCERIDES RESULT WAS 8.59 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485267 ↗
• MalfunctionJul 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE TEST RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE FOLLOWING ASSAYS WERE AFFECTED: CHOLESTEROL GEN.2 AND HDL-CHOLESTEROL. SAMPLE 1: THE INITIAL CHOLESTEROL RESULT WAS 43.4 MG/DL, AND THE REPEATED RESULT WAS 231 MG/DL. THE INITIAL HDL RESULT WAS 4.94 MG/DL, AND THE REPEATED RESULT WAS 55.4 MG/DL. SAMPLE 2: ON (B)(6) 2025, THE INITIAL CHOLESTEROL RESULT WAS 39.9 MG/DL, AND THE REPEATED RESULT WAS 110 MG/DL. THIS MEDWATCH WILL APPLY TO THE CHOLESTEROL GEN.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE HDL-CHOLESTEROL ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545803 ↗
• MalfunctionJul 16, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CHOLESTEROL GEN.2 (CHOL2) ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 346 MG/DL. THE CUSTOMER REPEATED THE SAMPLE TWICE WITH RESULTS OF 226 MG/DL AND 224 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520897 ↗
• MalfunctionMar 12, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 77.3 MG/DL AND IT REPEATED AS 237 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586436 ↗
• MalfunctionFeb 20, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 (CHOL2) ASSAY ON A COBAS C503 ANALYTICAL UNIT. INITIAL RESULT: 0.423 MMOL/L. THE CUSTOMER DIDN'T BELIEVE THE INITIAL RESULT AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. 1ST REPEAT RESULT: 4.78 MMOL/L. HOMOGENIZATION OF THE SAMPLE WAS PERFORMED BEFORE REPEATING IT FOR THE 2ND TIME. 2ND REPEAT RESULT: 4.80 MMOL/L. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422102 ↗
• MalfunctionDec 12, 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 C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 29.0 MG/DL. THE REPEAT RESULT WAS 178 MG/DL WHICH WAS CONSIDERED TO BE CORRECT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916870 ↗
• MalfunctionJul 17, 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 C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 4.01 MG/DL AND THE REPEAT RESULT WAS 166 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763724 ↗
• MalfunctionMar 14, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE INTEGRA CHOLESTEROL GEN. 2 (CHOL2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 9 MG/DL. THE REPEAT RESULT WAS 234 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901699 ↗
• MalfunctionDec 18, 2023Chemical Problem; Chemical Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOL2 CHOLESTEROL GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS AROUND 40 MG/DL. THE REPEAT RESULT WAS AROUND 200 MG/DL. THE EXACT RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343785 ↗
• MalfunctionApr 10, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CHOL2 CHOLESTEROL GEN.2 ON COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 702 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE DOCTOR REQUESTED A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 261 MG/DL. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 260 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708536 ↗
• MalfunctionJan 5, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CHOLESTEROL GEN.2 (CHOL2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 15.5 MMOL/L. ON (B)(6) 2022 THE SAMPLE WAS REPEATED WITH RESULTS OF 7.72 MMOL/L AND 7.68 MMOL/L. THE QUESTIONABLE HIGH RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CHOL2 REAGENT LOT NUMBER WAS 658312 WITH AN EXPIRATION DATE OF 31-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102239 ↗

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,