Dimension Vista® Flex® reagent cartridge CA19-9 10464358Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768028533), received between Oct 16, 2019 and Aug 31, 2021 — 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.

• MalfunctionAug 31, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CANCER ANTIGEN 19 (CA19-9) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM DURING VALIDATION OF A NEW CA 19-9 LOT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392361 ↗
• MalfunctionOct 16, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CANCER ANTIGEN 19-9 (CA 19-9) RESULTS WERE OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE VISTA INSTRUMENT AND A DISCORDANT ELEVATED RESULT WAS OBTAINED. DUE TO ELEVATED CA 19-9 RESULT, A CAT SCAN (CT) WITH CONTRAST WAS PERFORMED ON THE PATIENT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND WAS SENT TO AN ALTERNATE FACILITY AND WAS PROCESSED ON THREE ALTERNATE NON-SIEMENS INSTRUMENTS. LOWER RESULTS WERE OBTAINED WHICH WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CA 19-9 RESULTS OR DUE TO THE CAT SCAN PERFORMED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198363 ↗
• MalfunctionOct 16, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CANCER ANTIGEN 19-9 (CA 19-9) RESULTS WERE OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE VISTA INSTRUMENT AND A DISCORDANT ELEVATED RESULT WAS OBTAINED. DUE TO ELEVATED CA 19-9 RESULT, A CAT SCAN (CT) WITH CONTRAST WAS PERFORMED ON THE PATIENT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND WAS SENT TO AN ALTERNATE FACILITY AND WAS PROCESSED ON THREE ALTERNATE NON-SIEMENS INSTRUMENTS. LOWER RESULTS WERE OBTAINED WHICH WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CA 19-9 RESULTS OR DUE TO THE CAT SCAN PERFORMED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198357 ↗
• MalfunctionOct 16, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CANCER ANTIGEN 19-9 (CA 19-9) RESULTS WERE OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. SIEMENS TECHNICAL APPLICATIONS SPECIALIST (TAS) PROCESSED AN UNDILUTED SAMPLE FROM THE PATIENT AND OBTAINED AN ELEVATED RESULT WHICH WAS CONSIDERED DISCORDANT. THE SAME SAMPLE WAS REPROCESSED WITH DILUTIONS AND LOWERS RESULTS WERE OBTAINED. THE TAS PERFORMED A NEW CALIBRATION WITH A NEW CALIBRATOR AND THE SAMPLE SHOWED AN ELEVATED RESULT WHEN PROCESSED UNDILUTED AND LOWER RESULTS WHEN DILUTED. AFTER TREATMENT FOR HETEROPHILE ANTIBODIES, THE SAMPLE GAVE A LOWER RESULT. DUE TO ELEVATED CA 19-9 RESULTS, A CAT SCAN (CT) WITH CONTRAST WAS PERFORMED ON THE PATIENT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CA 19-9 RESULTS OR DUE TO THE CAT SCAN PERFORMED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198356 ↗
• MalfunctionOct 16, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CANCER ANTIGEN 19-9 (CA 19-9) RESULTS WERE OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE VISTA INSTRUMENT AND A DISCORDANT ELEVATED RESULT WAS OBTAINED. DUE TO ELEVATED CA 19-9 RESULT, A CAT SCAN (CT) WITH CONTRAST WAS PERFORMED ON THE PATIENT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND WAS SENT TO AN ALTERNATE FACILITY AND WAS PROCESSED ON THREE ALTERNATE NON-SIEMENS INSTRUMENTS. LOWER RESULTS WERE OBTAINED WHICH WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CA 19-9 RESULTS OR DUE TO THE CAT SCAN PERFORMED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198355 ↗
• MalfunctionOct 16, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CANCER ANTIGEN 19-9 (CA 19-9) RESULTS WERE OBTAINED ON A PATIENT SERUM/PLASMA SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE VISTA INSTRUMENT AND A DISCORDANT ELEVATED RESULT WAS OBTAINED. DUE TO ELEVATED CA 19-9 RESULT, A CAT SCAN (CT) WITH CONTRAST WAS PERFORMED ON THE PATIENT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND WAS SENT TO AN ALTERNATE FACILITY AND WAS PROCESSED ON THREE ALTERNATE NON-SIEMENS INSTRUMENTS. LOWER RESULTS WERE OBTAINED WHICH WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CA 19-9 RESULTS OR DUE TO THE CAT SCAN PERFORMED ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198354 ↗