Dimension® Flex® reagent cartridge RCRP 10444903Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768014130), received between Feb 5, 2019 and Feb 5, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED C-REACTIVE PROTEIN (RCRP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. A NEW SAMPLE FROM THE SAME PATIENT WAS PROCESSED USING TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED RCRP RESULT OR DUE THE PATIENT'S ANTIBIOTIC TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304771 ↗
• MalfunctionFeb 5, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED C-REACTIVE PROTEIN (RCRP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. A NEW SAMPLE FROM THE SAME PATIENT WAS PROCESSED USING TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED RCRP RESULT OR DUE THE PATIENT'S ANTIBIOTIC TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304770 ↗
• MalfunctionFeb 5, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED C-REACTIVE PROTEIN (RCRP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. A NEW SAMPLE FROM THE SAME PATIENT WAS PROCESSED USING TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED RCRP RESULT OR DUE THE PATIENT'S ANTIBIOTIC TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304764 ↗
• MalfunctionFeb 5, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED C-REACTIVE PROTEIN (RCRP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. A NEW SAMPLE FROM THE SAME PATIENT WAS PROCESSED USING TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED RCRP RESULT OR DUE THE PATIENT'S ANTIBIOTIC TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304763 ↗
• MalfunctionFeb 5, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED C-REACTIVE PROTEIN (RCRP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. A NEW SAMPLE FROM THE SAME PATIENT WAS PROCESSED USING TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED RCRP RESULT OR DUE THE PATIENT'S ANTIBIOTIC TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304761 ↗
• MalfunctionFeb 5, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED C-REACTIVE PROTEIN (RCRP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. A NEW SAMPLE FROM THE SAME PATIENT WAS PROCESSED USING TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ELEVATED RCRP RESULT OR DUE THE PATIENT'S ANTIBIOTIC TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304760 ↗