Events

Recall of DRUGCHECK DRUG SCREEN CUP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EXPRESS DIAGNOSTICS INTERNATIONAL 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
    43442
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-27
  • 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
    Affected lots of edi's drugs of abuse tests have shown reduced reactivity for up to three (3) of the nineteen (19) benzodiazepine compounds for which specificity information is provided in the product insert. specific compounds for which there may be reduced reactivity include clonazepam nordiazepam and lorazepam. the test continues to perform as expected for other drugs.

Device

DRUGCHECK DRUG SCREEN CUP
  • Model / Serial
    Model Catalog: X6XXXXXX (Lot serial: PE-04142); Model Catalog: X6XXXXXX (Lot serial: PE-03190); Model Catalog: X6XXXXXX (Lot serial: PE-02248); Model Catalog: X6XXXXXX (Lot serial: PD-11016); Model Catalog: X6XXXXXX (Lot serial: PE-02220); Model Catalog: X6XXXXXX (Lot serial: PD-12158); Model Catalog: X6XXXXXX (Lot serial: PD-12075); Model Catalog: X6XXXXXX (Lot serial: PD-02271); Model Catalog: X6XXXXXX (Lot serial: PD-12007); Model Catalog: X6XXXXXX (Lot serial: PD-03359); Model Catalog: X6XXXXXX (Lot serial: PD-01224); Model Catalog: X6XXXXXX (Lot serial: PD-02146); Model Catalog: X6XXXXXX (Lot serial: PD-01118); Model Catalog: X6XXXXXX (Lot serial: PD-02268); Model Catalog: X6XXXXXX (Lot serial: PC-12141); Model Catalog: X6XXXXXX (Lot serial: PC-12185); Model Catalog: X6XXXXXX (Lot serial: PD-02270); Model Catalog: X6XXXXXX (Lot serial: PD-03096); Model Catalog: X6XXXXXX (Lot serial: PC-11125); Model Catalog: X6XXXXXX (Lot serial: PD-01119); Model Catalog: X6XXXXXX (Lot serial: PE-05108); Model Catalog:
  • Product Description
    DRUGCHECK DRUG SCREEN CUP
  • Manufacturer
    EXPRESS DIAGNOSTICS INTERNATIONAL INC.

Manufacturer

EXPRESS DIAGNOSTICS INTERNATIONAL INC.