Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge HCG 10444913Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842768013850), received between Aug 21, 2018 and Dec 26, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED (1) ONE ERRONEOUSLY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED WITH A DILUTION ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020592 ↗
• MalfunctionApr 2, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM ON (B)(6) 2024. THE HIGHER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020722 ↗
• MalfunctionJan 19, 2024Low Test Results; Low Test Results

  A DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE WAS NO FOLLOW UP TESTING FOR THE PATIENT. THE PATIENT WAS FOUND TO BE PREGNANT AT A LATER DATE (DATE NOT PROVIDED). THE DOCTOR STATED WHEN THE HCG WAS RUN ON (B)(6) 2023 THE PATIENT'S LAST MISSED MENSES WAS ON (B)(6) 2023. IT IS UNKNOWN AT THIS TIME AS TO WHEN (DATE/DAYS AFTER LAST MENSTRUAL PERIOD) THE PATIENT WAS DIAGNOSED AS PREGNANT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543915 ↗
• MalfunctionMar 11, 2019High Test Results; High Test Results

  A DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE DIMENSION INSTRUMENTS AND A SIMILARLY ELEVATED RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE METHODOLOGIES AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED HCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410043 ↗
• MalfunctionMar 11, 2019High Test Results; High Test Results

  A DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE RESULT WAS QUESTIONED AT A LATER DATE WHEN A NEW SAMPLE WAS REPROCESSED WITH TWO ALTERNATE METHODOLOGIES AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED HCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410040 ↗
• MalfunctionMar 11, 2019High Test Results; High Test Results

  A DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. A SAMPLE DRAWN ON A LATER DATE FROM THE SAME PATIENT WAS REPROCESSED ON TWO ALTERNATE METHODOLOGIES AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED HCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410039 ↗
• MalfunctionMar 11, 2019High Test Results; High Test Results

  A DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE RESULT WAS QUESTIONED AT A LATER DATE WHEN A NEW SAMPLE WAS REPROCESSED WITH TWO ALTERNATE METHODOLOGIES AND A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED HCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410019 ↗
• MalfunctionDec 13, 2018High Test Results; High Test Results

  A DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED AT AN ALTERNATE FACILITY ON AN ALTERNATE SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162387 ↗
• MalfunctionNov 9, 2018Low Test Results; Low Test Results

  DISCORDANT DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION EXL WITH LM SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPROCESSED THE SAME DAY AT AN ALTERNATE FACILITY AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. NO TREATMENT WAS PROVIDED TO THE PATIENTS ON THE BASIS OF THE REPORTED DISCORDANT HCG RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054859 ↗
• MalfunctionNov 9, 2018Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON PATIENT SAMPLE ON THE DIMENSION EXL WITH LM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN (WHO QUESTIONED THE RESULT). THE SAME SAMPLE WAS REPROCESSED THE SAME DAY AT AN ALTERNATE FACILITY AND A HIGHER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. NO TREATMENT WAS PROVIDED TO THE PATIENT ON THE BASIS OF THE REPORTED DISCORDANT HCG RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054856 ↗
• MalfunctionAug 21, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON THE SAME SYSTEM AND A HIGHER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802639 ↗