Events

Recall of RX DAYTONA SYSTEM - LIPASE

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

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
    40091
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-25
  • 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
    Reagent probe carryover has been observed from triglycerides and direct ldl reagents to lipase reagent on the rx daytona rx daytona+ and rx imola analysers causing elevated lipase test results. it occurs when the lipase is tested directly before or after triglycerides or direct ldl in the test running order. it is also possible that this may occur on other instrumentation.

Device

RX DAYTONA SYSTEM - LIPASE
  • Model / Serial
    Model Catalog: LI3837 (Lot serial: Not batch specific)
  • Product Description
    RX DAYTONA SYSTEM - LIPASE
  • Manufacturer
    RANDOX LABORATORIES LTD.

Manufacturer

RANDOX LABORATORIES LTD.