Lipase colorimetric assay 3029590322Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04015630917570), received between Aug 16, 2018 and Apr 1, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 9 most recent of 9 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 LIPASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE CHOLESTEROL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE LDL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE HDL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT(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 24756824 ↗
• MalfunctionNov 7, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 248.6 U/L. THE REPEAT RESULT WAS 31.4 U/L. THE INITIAL RESULT WAS DEEMED ELEVATED AND NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WITHIN THE NORMAL RANGE WAS REPORTED BASED ON THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498210 ↗
• MalfunctionJul 17, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FROM THE COBAS 6000 C501 MODULE THAT DO NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. THE INITIAL RESULT WAS >446.7 U/L, AND THE AUTOMATIC REPEAT RESULT WAS 513.3 U/L. A NEW SAMPLE WAS DRAWN FROM THE PATIENT ON 18-JUN-2015, AND THE RESULT WAS 34.1 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530754 ↗
• MalfunctionFeb 10, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LIPC RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 311 ANALYZER. SAMPLE 1: THE INITIAL RESULT WAS 734.0 U/L. THE SAMPLE WAS TESTED AT ANOTHER LABORATORY, USING A DIFFERENT PLATFORM (REFLECTANCE METHOD) AND THE RESULT WAS 2,000 U/L. ON (B)(6) 2025 THE SAMPLE WAS REPEATED ON THE COBAS MODULE AND THE RESULTS WERE 329 U/L WITH A DATA FLAG, 431.0 U/L, AND 422 U/L. ON (B)(6) 2025 THE SAMPLE WAS REPEATED ON THE COBAS MODULE AND THE RESULT WAS 469.7 U/L. SAMPLE 2: ON (B)(6) 2025 THE INITIAL RESULT WAS 342 U/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A MANUAL DILUTION OF 1:50 AND THE RESULT WAS 600 U/L. THE SAMPLE WAS TESTED AT ANOTHER LABORATORY AND THE RESULT WAS 2,226 U/L. ON (B)(6) 2025 THE SAMPLE WAS TESTED AND THE RESULTS WERE 477 U/L AND 582 U/L (WITH A 1:20 DILUTION). THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT MATCHING THE PATIENTS' CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344717 ↗
• MalfunctionJul 12, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE LIPC (LIPASE COLORIMETRIC ASSAY) ASSAY ON A COBAS 4000 C311 STAND ALONE SYSTEM (SERIAL NUMBER (B)(6). THE INITIAL REPORTER ALSO MENTIONED RANDOM QUALITY CONTROL ERRORS. THE SAMPLE INITIALLY RESULTED IN AN LIPC VALUE OF 83 U/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED RESULTING IN A VALUE OF 30 U/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309419 ↗
• MalfunctionMar 15, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION RESULTS FOR 1 PATIENT ON A COBAS 6000 C 501 MODULE. ON (B)(6)2023, THE INITIAL LDL RESULT WAS 714 U/L. THE SAMPLE WAS DILUTED AND REPEATED AND THE RESULT WAS 750 U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6)2023, ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE LDL RESULT WAS 40 U/L. ON (B)(6)2023, A THIRD SAMPLE WAS COLLECTED FROM THE PATIENT. THE SAMPLE WAS RUN ON THE CUSTOMER'S C501 ANALYZER AND THE RESULT WAS 36 U/L. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548085 ↗
• MalfunctionSep 23, 2021Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE LIPC LIPASE COLORIMETRIC RESULT FOR ONE PATIENT SAMPLE WITH COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE INITIAL RESULT WAS 12,116 U/L. ON (B)(6) 2021, A SECOND SAMPLE WAS TESTED WITH A RESULT OF 65 U/L. BOTH RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AS HE THOUGHT THE VALUE DECREASED TOO FAST AFTER TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519152 ↗
• MalfunctionApr 24, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. ERRONEOUS NON-REPRODUCIBLE RESULTS WERE GENERATED BY A COBAS 6000 C (501) MODULE. THE EVENT INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE ERRONEOUS RESULT FOR THE LIPC LIPASE COLORIMETRIC ASSAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544222 ↗
• MalfunctionAug 16, 2018High Test Results; High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 7788168 ↗