Events

Recall of AQUIOS LYSING 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
    59306
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-19
  • 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 use of aquios lyse reagent kit lot numbers 6040014k and 6040015k may lead to an increased generation of notifications and flags when used on the aquios cl when running the aquios tetra application. the issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. depending on the specimen age a new blood specimen may be required.

Device

AQUIOS LYSING REAGENT KIT
  • Model / Serial
    Model Catalog: B23558 (Lot serial: 6040015K); Model Catalog: B23558 (Lot serial: 6040014K)
  • Product Description
    AQUIOS LYSE REAGENT KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.