Events

Recall of 634 ISE ICALCIUM/PH ANALYZER

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
    50171
  • Event Risk Class
    II
  • Event Initiated Date
    2000-01-19
  • 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
    Increase in qc values on ph when using these lots. elevated microbial levels isolated to some bottles specific to these lots may have contributes to this shift.

Device

634 ISE ICALCIUM/PH ANALYZER
  • Model / Serial
    Model Catalog: (Lot serial: 9F001 9G010)
  • Product Description
    model 634 reagent pack for analyzer
  • Manufacturer
    BAYER INC.

Manufacturer

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