Dimension Vista® System FPSA Flex® Reagent Cartridge 10445091Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768016677), received between Aug 27, 2021 and Sep 3, 2021 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED FREE PROSTATE SPECIFIC ANTIGEN (FPSA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS PROCESSED ON A LATER DATE AND NON-LINEAR RESULTS WERE OBTAINED. NO CORRECTED REPORT WAS ISSUED. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED FPSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423169 ↗
• MalfunctionAug 27, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED FREE PROSTATE SPECIFIC ANTIGEN (FPSA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME SYSTEM AND A LOWER RESULT WAS OBTAINED UPON DILUTION. THE CUSTOMER SENT OUT THE PATIENT'S SAMPLE TO A REFERENCE LABORATORY FOR TESTING USING A NON-SIEMENS METHODOLOGY. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED FPSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377242 ↗
• MalfunctionAug 27, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED FREE PROSTATE SPECIFIC ANTIGEN (FPSA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DATE AND A LOWER RESULT WAS OBTAINED AND REPORTED. THE CUSTOMER SENT OUT THE PATIENT'S SAMPLE TO A REFERENCE LABORATORY FOR TESTING USING A NON-SIEMENS METHODOLOGY. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED FPSA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377232 ↗