Events

Recall of Dimension Vista Calcium (CA) Flex 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
    74987
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-2017
  • Event Initiated Date
    2016-08-03
  • Event Date Posted
    2016-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149026
  • 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
    Cresolphthalein complexone, calcium - Product Code CIC
  • Reason
    Siemens healthcare diagnostics determined that the dimension vista calcium (ca) flex reagent cartridge lot # 16060bb may produce erroneously low or high results from specific well sets.
  • Action
    Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB. The notification letter requested that customers discontinue use and discard the affected kit.

Device

Dimension Vista Calcium (CA) Flex Reagent Cartridge
  • Model / Serial
    Device Listing No: D011443 Batch Number 16060BB
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.
  • Product Description
    Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge || Device Listing No.: D011443 || Batch Number: 16060BB
  • 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