Events

Recall of Device Recall Dimension Vista (R) Enzyme 1 Calibrator (ENZ 1 CAL)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67235
  • Event Risk Class
    Class 2
  • Event Number
    Z-1076-2014
  • Event Initiated Date
    2014-01-06
  • Event Date Posted
    2014-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125055
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calibrator, multi-analyte mixture - Product Code JIX
  • Reason
    Complaints were received regarding quality control (qc) shifts with pseudocholinesterase (pche) and imprecision during pche calibration with the dimension vista enzyme 1 calibrator (enz 1 cal).
  • Action
    A recall notification letter, dated January 2014, was sent to Users.

Device

Device Recall Dimension Vista (R) Enzyme 1 Calibrator (ENZ 1 CAL)
  • Model / Serial
    lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. || An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA