Events

Recall of RET-SEARCH II

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

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
    150440
  • Event Risk Class
    III
  • Event Initiated Date
    2009-11-03
  • 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
    Several boxes of ret-search ii (red-700a) manufactured on july 15 2009 had an incorrect bar code label applied to the product box. the bar code label identified the product as stromatolyser-nr with the same lot number and expiration date. the box contains a reagent bottle and dye pouch both of which were correctly labelled and the contents of the bottle and dye pouch are of the proper chemical composition for ret-search ii and passed all in-process and final inspection test criteria.

Device

RET-SEARCH II
  • Model / Serial
    Model Catalog: RED-700A (Lot serial: ZY9021)
  • Product Description
    RET-SEARCH II
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    HC