Dimension Vista® Flex® reagent cartridge ACTM 10445110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768015014), received between Dec 19, 2017 and Feb 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2021Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED ACETAMINOPHEN (ACTM) PATIENT RESULT WAS OBTAINED ON A DIMENSION VISTA® 1500 INTELLIGENT LAB SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED WITH DILUTION ON THE ORIGINAL SYSTEM. A HIGHER RESULT WAS OBTAINED. THE HIGHER RESULT WAS REPORTED ON A CORRECTED REPORT. A NEW PATIENT SAMPLE WAS DRAWN AND PROCESSED ON AN ALTERNATE INSTRUMENT DIMENSION VISTA SYSTEM. A DISCORDANT FALSELY DEPRESSED ACTM RESULT WAS OBTAINED ON THAT SYSTEM AND THE RESULT WAS NOT REPORTED. THE SAMPLE WAS REPROCESSED WITH DILUTION AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED ACTM RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375233 ↗
• MalfunctionDec 19, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED, ACETAMINOPHEN (ACTM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER STATED THAT THE PATIENT WAS TREATED BASED ON THE DISCORDANT FALSELY ELEVATED RESULT ON THEIR BELIEF OF AN ACETAMINOPHEN OVERDOSE. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED TO THE PATIENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT OR TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130825 ↗

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