Events

Recall of SALMONELLA ANTISERUM H:T

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CEDARLANE CORPORATION.

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
    85166
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-17
  • 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
    A decrease in antibody level was detected in this lot which means that agglutination with salmonella strains having weak expression of h:gmst and h:fgt appears after the definition of a positive reaction (10 sec) and therefore would be conceived as negative when in fact it is a positive.

Device

SALMONELLA ANTISERUM H:T
  • Model / Serial
    Model Catalog: 40336 (Lot serial: 696H-H6)
  • Product Description
    SALMONELLA ANTISERUM H:T
  • Manufacturer
    CEDARLANE CORPORATION

Manufacturer

CEDARLANE CORPORATION