Lipase colorimetric assayRecalls & reported problems across all models

We found 2 models of Lipase colorimetric assay by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2018 and Sep 16, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “High Test Results” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Lipase colorimetric assay problems

Lipase colorimetric assay models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Lipase colorimetric assay 08057982190

  LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
  11 reports
• Lipase colorimetric assay 3029590322

  LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
  9 reports

Recent Lipase colorimetric assay adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787538 ↗
• MalfunctionAug 21, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375915 ↗
• 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 ↗
• MalfunctionFeb 12, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO SB ANALYZER. THE INITIAL RESULT WAS 396 U/L. THE PATIENT HAD A NEW SAMPLE COLLECTED AT ANOTHER HOSPITAL AND THE RESULT WAS 67 U/L. THE PATIENT ALSO HAD A RESULT OF 400 U/L FROM ANOTHER COBAS PRO MODULE IN ANOTHER LABORATORY. THE SAME REAGENT LOT USED FOR THE INITIAL SAMPLE WAS UTILIZED. CLARIFICATION ON WHETHER THIS WAS A REPEAT RESULT FROM THE FIRST OR SECOND SAMPLE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320634 ↗
• MalfunctionDec 17, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THERE WAS A POTENTIAL INTERFERENCE. THE RESULTS WERE 33.6 U/L AND 34.6 U/L > ACCOMPANIED BY DATA FLAGS. A MANUAL 1:20 DILUTION 1WAS PERFORMED AND THE RESULT WAS 27.9 U/L ( X 20 = 558 U/L). THE SAMPLE WAS RETESTED UNDILUTED ON ANOTHER ANALYZER, AND THE RESULT WAS 35.7 U/L. A NEW MANUAL 1:10 DILUTION WAS PERFORMED, AND THE RESULTS WERE 40.9 U/L WITH A DATA FLAG (X 10= 409 U/L) AND 41.7 U/L (X 10=417 U/L). ON (B)(6) 2025, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT, AND THE RESULTS WERE 34.1 U/L AND 34.5 U/L. A NEW 1:10 MANUAL DILUTION WAS PERFORMED, AND THE RESULTS WERE 40.5 U/L WITH A DATA FLAG ( X 10=405), 40.8 U/L ( X 10=408), AND 42.6 U/L (X 10=426).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830132 ↗
• MalfunctionDec 2, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH LIPASE COLORIMETRIC ASSAY ON A COBAS C 503 ANALYTICAL UNIT, NOT CONSISTENT WITH THE PATIENT'S CONDITION. INITIAL RESULT: 615 U/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS HIGH AND WAS NOT CONSISTENT WITH THE PATIENT'S CONDITION. THE PHYSICIAN REQUESTED A NEW SAMPLE TO BE DRAWN AND TESTED ON THE SAME COBAS C 503 ANALYTICAL UNIT, RESULTING IN A VALUE OF 86 U/L. THE ORIGINAL SAMPLE WAS THEN REPEATED ON A DIFFERENT COBAS ANALYTICAL UNIT AT THE CUSTOMER'S SITE, AND THE VALUE OF 615 U/L WAS CONFIRMED. THE SPECIFIC RESULT RECEIVED WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696493 ↗
• MalfunctionNov 20, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE ANALYZER WAS BEING SERVICED BY A FIELD SERVICE ENGINEER AT THE TIME WHEN THE INITIAL RESULT WAS PRODUCED WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE INITIAL RESULT WAS 13.5 U/L. THE SAMPLE WAS REPEATED ON ANOTHER C503 ANALYZER AND THE RESULT WAS 42.0 U/L. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606855 ↗
• 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 ↗
• MalfunctionNov 5, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR FOUR PATIENTS. PATIENT 1'S INITIAL RESULT WAS 81.3 U/L, AND THE REPEAT RESULT WAS 43.3 U/L. PATIENT 2'S INITIAL RESULT WAS 87.9 U/L, AND THE REPEAT RESULT WAS 41.7 U/L. PATIENT 3'S INITIAL RESULT WAS 89.8 U/L, AND THE REPEAT RESULT WAS 48.5 U/L. PATIENT 4'S INITIAL RESULT WAS 78.0 U/L, AND THE REPEAT RESULT WAS 32.8 U/L. THE INITIAL RESULTS WERE QUESTIONED BECAUSE THE PATIENTS WERE HEALTHY. THE REPEAT RESULTS WERE PERFORMED WITH A NEW REAGENT LOT ON THE SAME INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478682 ↗
• MalfunctionJul 29, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TAKING PLAVIX AND TESTED FOR LIPASE COLORIMETRIC ASSAY (LIPC) ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT AFTER DILUTION WAS 552 U/L ON THE C303 ANALYZER. THE REPEAT RESULT WITH DILUTION WAS 572 U/L ON THE C303 ANALYZER. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, WHERE THE LIPASE RESULT FROM A NEW SAMPLE ON AN UNSPECIFIED COBAS SYSTEM WAS 40 U/L. ON (B)(6) 2025, THE ORIGINAL SAMPLE WAS REPEATED ON THE C303 ANALYZER, AND THE RESULTS WERE 444 U/L AND 583 U/L AFTER DILUTION. THE CUSTOMER SUSPECTS AN INTERFERENCE WITH PLAVIX AFFECTING THE RESULTS FROM THE C303 ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642044 ↗
• 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 ↗
• MalfunctionMar 24, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR LIPASE COLORIMETRIC ASSAY (LIPC) ON A COBAS C 303 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 96.4 U/L. ON (B)(6) 2025 THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 40.6 U/L AND 41.0 U/L. ON (B)(6) 2025 PATIENT 2 INITIAL RESULT WAS 71.7 U/L. THE REPEAT RESULT WAS 30.7 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677732 ↗
• 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 ↗
• MalfunctionAug 7, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR LIPASE COLORIMETRIC ASSAY (LIPC) AND A-AMYLASE EPS VER. 2 (AMYL2) ON 2 COBAS C 503 ANALYTICAL UNITS. THIS MEDWATCH WILL COVER LIPC. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AMYL2 RESULTS. ON (B)(6) 2024 THE INITIAL LIPC RESULT FROM C503 ANALYZER A WAS 292 U/L. THE AMYL2 RESULT WAS 161 U/L. ON (B)(6) 2024 THE PATIENT WAS TESTED IN A DIFFERENT LABORATORY USING A COBAS 6000 C501 MODULE WHERE THE LIPC RESULT WAS 38 U/L AND THE AMYL2 RESULT WAS 86 U/L. THESE RESULTS WERE BELIEVED TO BE CORRECT. ON (B)(6) 2024 THE ORIGINAL SAMPLE WAS REPEATED ON THE CUSTOMER'S BACKUP C503 ANALYZER B AND THE LIPC RESULT WAS 279 U/L AND THE AMYL2 RESULT WAS 164 U/L. ON (B)(6) 2024 A NEW SAMPLE WAS OBTAINED AND RUN ON C503 ANALYZER A WITH A LIPC RESULT OF 102 U/L AND AN AMYL2 RESULT OF 124 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929738 ↗
• MalfunctionAug 24, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LIPC (LIPASE) ON A COBAS PRO C 503 ANALYTICAL UNIT. ON (B)(6) 2023, A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A LIPASE VALUE OF 25 U/L. ON (B)(6) 2023, A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND RESULTED IN A LIPASE VALUE OF 698 U/L. ON (B)(6) 2023, A THIRD SAMPLE WAS COLLECTED FROM THE PATIENT AND RESULTED IN A LIPASE VALUE OF 22 U/L. THE RESULT FROM THE SECOND SAMPLE WAS QUESTIONED AS AN INCREASE OF 698 U/L WOULD NOT BE EXPECTED BASED ON THE LOWER RESULTS RECEIVED ON (B)(6) 2023 AND (B)(6) 2023. THE SECOND SAMPLE WAS REPEATED, RESULTING IN A LIPASE VALUE OF 713 U/L. THIS SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A LIPASE VALUE OF 768 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612027 ↗

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