Dimension® CSA Flex® reagent cartridge 10285193Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842768025136), received between Mar 5, 2020 and Feb 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY DEPRESSED CYCLOSPORINE A (CSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION RXL MAX HM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED TWICE ON THE ORIGINAL DIMENSION RXL MAX HM INTEGRATED CHEMISTRY SYSTEM. HIGHER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. THE HIGHER REPROCESSED RESULT OF 116.3 NG/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CYCLOSPORINE A (CSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466684 ↗
• MalfunctionJul 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY ELEVATED CYCLOSPORINE A (CSA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS MANUALLY DILUTED AND REPROCESSED TWO TIMES ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CYCLOSPORINE A (CSA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642732 ↗
• MalfunctionJun 2, 2023High Test Results; High Test Results

  TWO (2) DISCORDANT FALSELY ELEVATED CYCLOSPORINE A (CSA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. ONE OF THE FALSELY ELEVATED RESULTS WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL 200 SYSTEM, AND THE REPROCESSED RESULT WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CYCLOSPORINE A (CSA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049053 ↗
• MalfunctionMar 5, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY DEPRESSED CYCLOSPORINE A (CSA) RESULTS WERE OBTAINED ON PATIENTS' SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). AFTER A NEW FLEX WAS PUT ON-BOARD AND A RE-CALIBRATION WAS PERFORMED, EACH PATIENT SAMPLE WAS REPROCESSED ON THE SAME DATE ON THE INSTRUMENT AND A HIGHER CORRECT RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE DISCORDANT, FALSELY DEPRESSED CYCLOSPORINE A RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795378 ↗