Recall of COCAINE METABOLITE MICRO-PLATE EIA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORASURE TECHNOLOGIES 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
    103242
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-16
  • Event Country
  • 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
    Cocaine microplate kit failed the six month stability time point at initial testing as well as double operator repeat testing. a nonconformance report was intiated. the product may produce false positive patient results. the product provides only a preliminary analytical test result. a more specific alternative method should be used in order to obtain a confirmed analytical result.

Device

  • Model / Serial
    Model Catalog: 1122S(BC) (Lot serial: 6661251)
  • Product Description
    COCAINE METABOLITE MICRO-PLATE EIA
  • Manufacturer

Manufacturer