Events

Recall of Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CSL Behring GmbH.

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
    74468
  • Event Risk Class
    Class 2
  • Event Number
    Z-2241-2016
  • Event Initiated Date
    2016-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147669
  • 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
    Reagent lots # 15243ma and 15243mb shows a reduced stability once opened that does not meet the instructions for use claim of seven (7) days. a maximum bias of -37% was observed.
  • Action
    Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days.

Device

Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)
  • Model / Serial
    Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV
  • Product Description
    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
  • Manufacturer
    CSL Behring GmbH

Manufacturer

CSL Behring GmbH
  • Manufacturer Address
    CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg Germany
  • Manufacturer Parent Company (2017)
    CSL Limited
  • Source
    USFDA