Events

Recall of WHATMAN BODY FLUID COLLECTION PAPER 903

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GE HEALTHCARE BIO-SCIENCES CORP..

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
    32163
  • Event Risk Class
    III
  • Event Initiated Date
    2010-05-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Whatman has received a small number of reports of a quality issue where partial or complete detachment of the 903 paper from the demographic portion of the card has occurred.

Device

WHATMAN BODY FLUID COLLECTION PAPER 903
  • Model / Serial
    Model Catalog: 10534784 (Lot serial: ); Model Catalog: 10534751 (Lot serial: ); Model Catalog: 10534678 (Lot serial: ); Model Catalog: 10534567 (Lot serial: ); Model Catalog: 10534785 (Lot serial: ); Model Catalog: 10534804 (Lot serial: ); Model Catalog: 10534732 (Lot serial: )
  • Product Description
    Whatman 903 Newborn Screening Card
  • Manufacturer
    GE HEALTHCARE BIO-SCIENCES CORP.

Manufacturer

GE HEALTHCARE BIO-SCIENCES CORP.