Events

Recall of RPMI MEDIUM 1640

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDIATECH INC.-A CORNING SUBSIDIARY.

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
    147040
  • Event Risk Class
    III
  • Event Initiated Date
    2017-05-10
  • 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
    As part of an investigation into a suspect raw materialtesting concluded that the products in scope were unable to support the growth of the ng-108 cell line to a procedure-established minimum cell concentration.

Device

RPMI MEDIUM 1640
  • Model / Serial
    Model Catalog: 10-040-CV (Lot serial: 00317002); Model Catalog: 10-040-CV (Lot serial: 00817002)
  • Product Description
    RPMI MEDIUM 1640
  • Manufacturer
    MEDIATECH INC.-A CORNING SUBSIDIARY

Manufacturer

MEDIATECH INC.-A CORNING SUBSIDIARY
  • Manufacturer Address
    MANASSAS
  • Source
    HC