Dimension Vista® Flex® reagent cartridge SAL 10445108Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768015427), received between Jun 29, 2020 and Jun 29, 2020 — classified as 1 malfunction.

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

• MalfunctionJun 29, 2020High Test Results; High Test Results

  A DISCORDANT ELEVATED SALICYLATE (SAL) RESULT WAS OBTAINED ON A PATIENT SERUM SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS PROCESSED ON THE CUSTOMER'S ALTERNATE DIMENSION VISTA SYSTEM AND AN ELEVATED RESULT WAS OBTAINED. THE SAME SAMPLE WAS PROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM AND A LOWER RESULT WAS OBTAINED. THE PATIENT WAS ADMINISTERED A MEDICATION FOR SALICYLATE POISONING. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED SALICYLATE RESULT OR THE MEDICATION TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10206870 ↗

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