Dimension Vista® Flex® reagent cartridge GLU 10445162Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768015663), received between Feb 7, 2019 and Feb 7, 2019 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED GLUCOSE (GLU) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED THE SAME DAY WITH AN ALTERNATE, NON-SIEMENS METHODOLOGY AND A HIGHER RESULT WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED GLUCOSE RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316925 ↗

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-1658-2018 · Jun 29, 2017 · Terminated
  Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
• Z-1660-2018 · Jun 29, 2017 · Terminated
  Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (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