Events

Recall of Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge

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
    61465
  • Event Risk Class
    Class 2
  • Event Number
    Z-1433-2012
  • Event Initiated Date
    2012-02-17
  • Event Date Posted
    2012-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108165
  • 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
    Photometric method, magnesium - Product Code JGJ
  • Reason
    Firm has confirmed a negative shift of approximately 0.2mg/dl [0.08 mmol/l] in patient and qc samples when using vista magnesium.
  • Action
    Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299.

Device

Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge
  • Model / Serial
    Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
  • Product Description
    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, plasma and urine on the Dimension Vista(R) System
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA