Events

Recall of RETICPREP REAGENT KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    142034
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-04
  • 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
    The secondary barcode label for reticprep stain can not be scanned or manually entered into the instrument software. the secondary label contains characters that are not recognized by the software.

Device

RETICPREP REAGENT KIT
  • Model / Serial
    Model Catalog: 7546978 (Lot serial: 108912K)
  • Product Description
    ReticPrep Reagent Kit
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.