Dimension Vista® Flex® reagent cartridge TSH 10445104Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00842768015731), received between Jun 16, 2017 and Apr 29, 2022 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (16 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS SPLIT INTO DIFFERENT SAMPLES AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES ON THE SAME DATE. HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254056 ↗
• MalfunctionApr 29, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM WHICH WAS LATER DETERMINED TO BE DISCORDANT WHEN COMPARED TO THE RESULTS FROM ALTERNATE METHODOLOGIES ON A LATER DATE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED AT A LATER DATE. ON A LATER DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES AND HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT OR DUE TO THE POTENTIAL CHANGES IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254038 ↗
• MalfunctionApr 29, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM WHICH WAS LATER DETERMINED TO BE DISCORDANT WHEN COMPARED TO THE RESULTS FROM ALTERNATE METHODOLOGIES ON A LATER DATE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED AT A LATER DATE. ON A LATER DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES AND HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT OR DUE TO THE POTENTIAL CHANGES IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254011 ↗
• MalfunctionApr 29, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM WHICH WAS LATER DETERMINED TO BE DISCORDANT WHEN COMPARED TO THE RESULTS FROM ALTERNATE METHODOLOGIES ON A LATER DATE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED AT A LATER DATE. ON A LATER DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES AND HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT OR DUE TO THE POTENTIAL CHANGES IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254008 ↗
• MalfunctionApr 29, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM WHICH WAS LATER DETERMINED TO BE DISCORDANT WHEN COMPARED TO THE RESULTS FROM ALTERNATE METHODOLOGIES ON A LATER DATE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED AT A LATER DATE. ON A LATER DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES AND HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT OR DUE TO THE POTENTIAL CHANGES IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254005 ↗
• MalfunctionApr 29, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM WHICH WAS LATER DETERMINED TO BE DISCORDANT WHEN COMPARED TO THE RESULTS FROM ALTERNATE METHODOLOGIES ON A LATER DATE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE RESULT WAS QUESTIONED AT A LATER DATE. ON A LATER DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM, AND NON-SIEMENS SYSTEMS AT ALTERNATE FACILITIES AND HIGHER TSH RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED LOCI THYROID STIMULATING HORMONE (TSH) RESULT OR DUE TO THE POTENTIAL CHANGES IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253993 ↗
• MalfunctionDec 18, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED THYROID STIMULATING HORMONE (TSH) 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 A LOWER CORRECT RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TSH RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492041 ↗
• MalfunctionDec 18, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED THYROID STIMULATING HORMONE (TSH) 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 CUSTOMER TREATED THE PATIENT SAMPLE THE SAME DAY TO TEST FOR INTERFERENCE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TSH RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492037 ↗
• MalfunctionDec 18, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TSH RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492034 ↗
• MalfunctionMar 29, 2018Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. AFTER THE NEXT QC RUN WAS OUTSIDE OF APPROVED RANGE, THE SAME SAMPLE WAS RUN ON AN ALTERNATE DIMENSION VISTA SYSTEM, RESULTING HIGHER. THE REPEAT RESULT WAS REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383374 ↗
• MalfunctionMar 29, 2018Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). AFTER THE NEXT QC RUN WAS OUTSIDE OF APPROVED RANGE, THE SAME SAMPLES WERE RUN ON AN ALTERNATE DIMENSION VISTA SYSTEM, RESULTING HIGHER. THE REPEAT RESULTS WERE REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED TSH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383371 ↗
• MalfunctionNov 15, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS TESTED AT AN ALTERNATE FACILITY WITH AN ALTERNATE METHODOLOGY AND A HIGHER RESULT WAS OBTAINED. THE TSH RESULT OBTAINED ON THE ALTERNATE METHODOLOGY WAS REPORTED TO THE PHYSICIAN BECAUSE THE RESULT CORRELATED WITH THE CLINICAL CONTEXT OF THE PATIENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7035687 ↗
• MalfunctionJul 11, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 HIGHER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701693 ↗
• MalfunctionJul 10, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 HIGHER 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 DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699008 ↗
• MalfunctionJul 7, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 HIGHER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6695081 ↗
• MalfunctionJun 29, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6678896 ↗
• MalfunctionJun 26, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 HIGHER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667032 ↗
• MalfunctionJun 22, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659639 ↗
• MalfunctionJun 16, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED THYROID STIMULATING HORMONE (TSH) 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 DEPRESSED TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646615 ↗

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