Events

Recall of Dimension Vista HCYS

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
    66363
  • Event Risk Class
    Class 2
  • Event Number
    Z-0541-2014
  • Event Initiated Date
    2013-09-18
  • Event Date Posted
    2013-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122156
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Reason
    Dimension vista hcys lot 13064ma shows erratic recovery of qc and patient samples.
  • Action
    Siemens sent a Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be taken by Customer: Please discontinue use and discard any remaining inventory of Dimension Vista¿ HCYS Flex¿ reagent cartridge (Catalog# K7044) lot 13064MA. Please complete the attached form and fax it to (302) 631-8467 to facilitate your no charge replacement needs. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center- Technical Solutions or your local Siemens technical support representative. For further questions please call (800) 441-9250.

Device

Dimension Vista HCYS
  • Model / Serial
    lot 13064MA, expiration 2014-03-05
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.
  • Product Description
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge || The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
  • 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