Dimension Vista® Flex® reagent cartridge FT4 10445103Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00842768015205), received between Jun 16, 2017 and Dec 18, 2019 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 reports).

3 other recalls cover devices cleared under the same FDA submission (K140859); they may or may not involve this specific model.

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 13 most recent of 13 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 (FT4) 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 FT4 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492039 ↗
• MalfunctionJun 28, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT OBTAINING A LOWER RESULT. THE CUSTOMER STATED THAT THE PATIENT'S SCHEDULED DILATION AND CURETTAGE SURGERY WAS DELAYED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FT4 RESULT OR THE DELAY OF THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647969 ↗
• MalfunctionJun 28, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT OBTAINING A LOWER RESULT. THE CUSTOMER STATED THAT THE PATIENT'S SCHEDULED DILATION AND CURETTAGE SURGERY WAS DELAYED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FT4 RESULT OR THE DELAY OF THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647940 ↗
• MalfunctionJul 11, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701677 ↗
• MalfunctionJul 10, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699041 ↗
• MalfunctionJul 7, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6695095 ↗
• MalfunctionJul 7, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE CUSTOMER WAS UNABLE TO REPEAT THE SAMPLE; THEREFORE, NO CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693076 ↗
• MalfunctionJul 7, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS TESTED AT AN ALTERNATE FACILITY WITH AN ALTERNATE SIEMEN'S INSTRUMENT AND 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693066 ↗
• MalfunctionJul 7, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE CUSTOMER WAS UNABLE TO REPEAT THE SAMPLE; THEREFORE, NO CORRECTED REPORT WAS ISSUED. IT WAS ALLEGED THAT THE PHYSICIAN PRESCRIBED PROPYL-THYRACIL AS A RESULT OF THE DISCORDANT ELEVATED FT4 RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE PRESCRIBED MEDICATION OR THE DISCORDANT ELEVATED FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693055 ↗
• MalfunctionJun 29, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6678894 ↗
• MalfunctionJun 26, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667040 ↗
• MalfunctionJun 22, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE CUSTOMER DID NOT PERFORM REPEAT TESTING OR ISSUE A CORRECTED REPORT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT ELEVATED FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659649 ↗
• MalfunctionJun 16, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED FREE THYROXINE (FT4) 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 FT4 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646639 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140859. One submission often covers many models, so check the product and lot details in each record.

• Z-1673-2018 · Jan 2, 2018 · Terminated
  Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
• Z-2611-2017 · Mar 21, 2017 · Terminated
  Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
• Z-1708-2015 · Apr 20, 2015 · Terminated
  Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human ser