Dimension Lipase (LIP) Flex reagent cartridge 11538126Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414292748), received between May 15, 2024 and May 15, 2024 — classified as 2 malfunctions.

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

• MalfunctionMay 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED LIPASE (LIP) RESULTS ON TWO (2) PATIENT SAMPLES WHEN THE SAMPLES WERE REPROCESSED ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE DRAWN FROM THE SAME PATIENTS AND PROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. FOR THE SECOND PATIENT, ANOTHER NEW SAMPLE WAS DRAWN AND PROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED. THE CUSTOMER STATED THAT THE PATIENTS WERE ADMITTED TO THE HOSPITAL BASED ON THE ERRONEOUSLY ELEVATED LIP RESULTS. NO TREATMENT WAS GIVEN OR DELAYED AND THE PATIENTS WERE DISCHARGED FROM THE HOSPITAL WITHOUT ANY HARM. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LIPASE (LIP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319191 ↗
• MalfunctionMay 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED LIPASE (LIP) RESULTS ON TWO (2) PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. NEW SAMPLES WERE DRAWN FROM THE SAME PATIENTS AND PROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. FOR THE SECOND PATIENT, ANOTHER NEW SAMPLE WAS DRAWN AND PROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED. THE CUSTOMER STATED THAT THE PATIENTS WERE ADMITTED TO THE HOSPITAL BASED ON THE ERRONEOUSLY ELEVATED LIP RESULTS. NO TREATMENT WAS GIVEN OR DELAYED AND THE PATIENTS WERE DISCHARGED FROM THE HOSPITAL WITHOUT ANY HARM. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED LIPASE (LIP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319165 ↗