Dimension Vista® Flex® reagent cartridge PHOS 10445144Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768015700), received between Feb 26, 2018 and Feb 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2018Low Test Results; Low Test Results

  DISCORDANT DEPRESSED PHOSPHORUS (PHOS) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED. ONE PATIENT RECEIVED TREATMENT BASED ON THE DISCREPANT RESULT. THE SAME PATIENT SAMPLES WERE REPEATED AFTER RECALIBRATION OF THE SAME FLEX REAGENT CARTRIDGE WITH AN ALTERNATE FLEX WELL SET HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED PHOS RESULTS OR DUE TO PATIENT TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7297195 ↗

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-1666-2016 · Mar 17, 2016 · Terminated
  Dimension Vista Assays: Uric Acid (URCA)
• Z-1665-2016 · Mar 17, 2016 · Terminated
  Dimension Vista Assays: Triglycerides (TRIG)
• 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