Events

Recall of Device Recall Clearview Simplify

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inverness Medical Professional Diagnostics.

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
    37356
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-2007
  • Event Initiated Date
    2007-02-15
  • Event Date Posted
    2007-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50420
  • 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
    D-dimer, in vitro diagnostic - Product Code GHH
  • Reason
    Lot px018a is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
  • Action
    Recall notification letters were sent to all customers on 2/14/07 by first class mail.

Device

Device Recall Clearview Simplify
  • Model / Serial
    Kit lot number: PX018A Test device batch number: 682-024 Catalog Number: 6100KVC Expiration date: 3/2008
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, and Canada.
  • Product Description
    Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. || Product No. 61100KVC || 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide || 10 plastic pipettes || Wampole Laboratories || Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
  • Manufacturer
    Inverness Medical Professional Diagnostics

Manufacturer

Inverness Medical Professional Diagnostics
  • Manufacturer Address
    Inverness Medical Professional Diagnostics, 2 Research Way, Princeton NJ 08540-6628
  • Source
    USFDA