Dimension Vista® Flex® reagent cartridge FT3 10445106Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842768015199), received between Jun 16, 2017 and Dec 18, 2019 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED FREE THYROXINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED AT AN ALTERNATE FACILITY ON A NON-SIEMENS ALTERNATE METHODOLOGY AND ON AN ALTERNATE SIEMENS METHODOLOGY AND HIGHER CORRECT RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED FT3 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492019 ↗
• MalfunctionJul 11, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE TRIIODOTHYRONINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS TESTED AT AN ALTERNATE FACILITY WITH AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701686 ↗
• MalfunctionJul 10, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE TRIIODOTHYRONINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED WITH A NON-SIEMENS ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED AND REPORTED. THE PATIENT RESULTS WERE DELAYED 24 HOURS, WITHOUT ANY CONSEQUENCES TO THE PATIENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699056 ↗
• MalfunctionJul 7, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE TRIIODOTHYRONINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS TESTED AT AN ALTERNATE FACILITY WITH AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6695104 ↗
• MalfunctionJun 29, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREETRIIODOTHYRONINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WITHIN THE LABORATORY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6678950 ↗
• MalfunctionJun 26, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE TRIIODOTHYRONINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS TESTED AT AN ALTERNATE FACILITY WITH AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667048 ↗
• MalfunctionJun 16, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE TRIIODOTHYRONINE (FT3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646642 ↗