Cholesterol Gen.2 05168538190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630924967), received between Sep 29, 2022 and Sep 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CHOLESTEROL GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 0.25 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 3.9 MMOL/L. THE SAMPLE WAS TESTED 10 TIMES AND THE AVERAGE RESULT WAS 3.973 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097623 ↗
• MalfunctionFeb 26, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TRIGL TRIGLYCERIDES AND CHOL2 CHOLESTEROL GEN.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 701 MODULE. THIS MDR IS FOR THE CHOL2 ASSAY. PLEASE REFER TO MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE TRIGL ASSAY. THE REPORTED COMPLAINED THAT THE PATIENT SAMPLE HAD CHOL2 AND TRIGL RESULTS CLOSE TO ZERO BUT THE HDL-C AND LDL-C TOTALED TO OVER 100 MG/DL (HDL = 52 MG/DL; LDL = 53 MG/DL). THE PHYSICIAN DID NOT BELIEVE THE RESULTS BECAUSE THEY COULD NOT BE CORRECT AND WERE INCOMPATIBLE WITH LIFE. THE REPORTER STATED THAT THERE IS AN INTERFERENCE DUE TO THE THERAPY OF PARACETAMOL INTOXICATION INDICATED IN THE FOUR ASSAYS MENTIONED AND ALSO ANOTHER INTERFERENCE FOR THE CHOL2 AND TRIGL ASSAYS. ON (B)(6) 2024: THE INITIAL CHOL2 RESULT WAS <10 MG/DL. THE FIRST REPEAT RESULT WAS <10 MG/DL. ON (B)(6) 2024: THE SECOND REPEAT RESULT WAS <10 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776411 ↗
• MalfunctionSep 29, 2022No Device Output; No Device Output

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CHOL2 CHOLESTEROL GEN.2, ELECSYS TOTAL PSA IMMUNOASSAY, AND IRON2 IRON GEN.2 RESULTS FROM 1 PATIENT ON A COBAS 8000 COBAS C 701 MODULE. THE CUSTOMER WAS UNABLE TO OBTAIN PLAUSIBLE RESULTS FROM 1 PATIENT'S SAMPLES. THE DATES OF TESTING WERE (B)(6) 2022. ALL SAMPLES GAVE A RESULT OF "???" FOR ALL TESTS EXCEPT FOR IRON ON (B)(6) 2022. THE RESULT WAS REQUESTED BUT NOT PROVIDED. IT IS SUSPECTED THAT THERE MAY BE AN INTERFERING FACTOR IN THE PATIENT SAMPLE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4). THIS MEDWATCH WILL COVER CHOLESTEROL. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE PSA RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE IRON RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503359 ↗

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,