Dimension Vista® Flex® reagent cartridge VANC 10445128Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00842768015533), received between Sep 15, 2017 and Sep 11, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 reports).

7 other recalls cover devices cleared under the same FDA submission (K061655); 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.

• MalfunctionSep 11, 2026Low Test Results

  The customer reported that an erroneously depressed Vancomycin (VANC) result on a patient sample was obtained on a Dimension Vista 500 System. The Initial result was reported to the physician and questioned. The same sample was repeated on both original and alternate Dimension Vista 500 Systems. The repeat results obtained were higher than the initial result, matched the clinical history and were considered correct. The repeat result from an alternate system was reported as the correct result to the physician. There are no known reports of patient intervention or adverse health consequences due to the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733087 ↗
• MalfunctionOct 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) PATIENT RESULT ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE ERRONEOUS PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343797 ↗
• MalfunctionAug 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ONE (1) ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 AND AN ALTERNATE DIMENSION VISTA 500. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081871 ↗
• MalfunctionJun 14, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM WHEN THE SAMPLE WAS REPROCESSED. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM. A HIGHER REPROCESSED RESULT WAS OBTAINED, CONSIDERED CORRECT, MATCHED THE PRIOR INITIAL RESULT OBTAINED FOR THE SAME SAMPLE, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536134 ↗
• MalfunctionOct 25, 2021Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED VANCOMYCIN (VANC) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED TWICE ON THE ORIGINAL SYSTEM. THE HIGHER REPROCESSED RESULTS MATCHED THE PATIENT HISTORY. THE HIGHER REPROCESSED RESULT, CONSIDERED CORRECT, WAS REPORTED. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED PATIENT VANC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692717 ↗
• MalfunctionOct 8, 2020High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT, FALSELY ELEVATED, AND FALSELY DEPRESSED VANCOMYCIN (VANC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S), AND WERE QUESTIONED BY THE CUSTOMER. THE SAME SAMPLE WAS REPROCESSED MULTIPLE TIMES THE SAME DAY WITH THE SAME INSTRUMENT, AND LOWER AND HIGHER RESULTS WERE OBTAINED. ONE RESULT WAS REPORTED AND CONSIDERED CORRECT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED, AND DEPRESSED VANC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10652548 ↗
• MalfunctionFeb 21, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  DISCORDANT VANCOMYCIN (VANC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. AN ABNORMAL ASSAY FLAGGED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE VISTA INSTRUMENT AND ABNORMAL ASSAY FLAGGED RESULTS WERE ALSO OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VANC RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358257 ↗
• MalfunctionMay 11, 2018Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE VISTA INSTRUMENT AND A HIGHER RESULT WAS OBTAINED. A CORRECTED RESULT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED VANCOMYCIN (VANC) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7506193 ↗
• MalfunctionFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY DEPRESSED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN AND THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEATED RESULT WAS HIGHER. THE CUSTOMER RAN THE SAME PATIENT SAMPLE, IN DUPLICATE, USING SMALL SAMPLE CONTAINER (SSC). THE REPEATED RESULTS WERE HIGHER AND IN THE EXPECTED RANGE. THE CUSTOMER PERFORMED ADDITIONAL REPEAT TESTING ON A DIFFERENT DIMENSION VISTA INSTRUMENT AND THE RESULTS WERE ALSO HIGHER AND IN THE EXPECTED RANGE. THE CUSTOMER STATED THE REPEAT TEST RESULTS PERFORMED WITH THE SMALL SAMPLE CONTAINER (SSC) AND ON A DIFFERENT DIMENSION VISTA CORRELATED, AND A CORRECTED RESULT (14.5 UG/ML) WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY DEPRESSED VANC RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285492 ↗
• MalfunctionSep 15, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868161 ↗
• MalfunctionSep 15, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS RUN ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATED THAT THE VANCOMYCIN TREATMENT WAS STOPPED DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULT OR THE DISCONTINUANCE OF VANCOMYCIN TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868159 ↗
• MalfunctionSep 15, 2017High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED VANCOMYCIN (VANC) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE SAME DATE ON ONE INDIVIDUAL PATIENT ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS RUN ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATED THAT THE VANCOMYCIN TREATMENT WAS STOPPED DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULTS OR THE DISCONTINUANCE OF VANCOMYCIN TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868083 ↗
• MalfunctionSep 15, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED VANCOMYCIN (VANC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS RUN ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATED THAT THE VANCOMYCIN TREATMENT WAS STOPPED DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED VANC RESULT OR THE DISCONTINUANCE OF VANCOMYCIN TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6868077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061655. One submission often covers many models, so check the product and lot details in each record.

• Z-1660-2018 · Jun 29, 2017 · Terminated
  Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
• Z-1658-2018 · Jun 29, 2017 · Terminated
  Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
• Z-1665-2016 · Mar 17, 2016 · Terminated
  Dimension Vista Assays: Triglycerides (TRIG)
• Z-1666-2016 · Mar 17, 2016 · Terminated
  Dimension Vista Assays: Uric Acid (URCA)
• Z-0339-2016 · Sep 30, 2015 · Terminated
  Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimen
• Z-2175-2012 · Jul 17, 2012 · Terminated
  Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista sy
• Z-1433-2012 · Feb 17, 2012 · Terminated
  Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasm