Events

Recall of DCA 2000 - MICRO ALBUMIN/CREATININE TEST KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER 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
    56324
  • Event Risk Class
    III
  • Event Initiated Date
    1999-09-13
  • 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
    Variability in the individual results of albumin creatinine and the ratio of albumin to creatinine. a problem with one cartridge manufacturing run was identified during release testing.

Device

DCA 2000 - MICRO ALBUMIN/CREATININE TEST KIT
  • Model / Serial
    Model Catalog: (Lot serial: Lot No. 0988039 EXP March2001.)
  • Product Description
    DCA 2000 microalbumin creatinine reag
  • Manufacturer
    BAYER INC.

Manufacturer

BAYER INC.
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC