Events

Recall of MULTIGENT - AEROSET/C8000 HEMOGLOBIN A1C KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BGP PHARMA ULC.

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
    15106
  • Event Risk Class
    III
  • Event Initiated Date
    2006-03-17
  • 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
    Recent lots of reagents demonstrate a trend towards higher recover of % hba1c and customer inquiries indicate recovery of high values on the cap (college of american pathology) proficiency survey.

Device

MULTIGENT - AEROSET/C8000 HEMOGLOBIN A1C KIT
  • Model / Serial
    Model Catalog: 02K96-10 (Lot serial: 501215); Model Catalog: 02K96-10 (Lot serial: 502485); Model Catalog: 02K96-10 (Lot serial: 501517); Model Catalog: 02K96-02 (Lot serial: 501517); Model Catalog: 02K96-02 (Lot serial: 501215); Model Catalog: 02K96-02 (Lot serial: 502485); Model Catalog: 02K96-02 (Lot serial: 500931); Model Catalog: 02K96-10 (Lot serial: 500931); Model Catalog: 02K96-10 (Lot serial: 401781); Model Catalog: 02K96-02 (Lot serial: 401781); Model Catalog: 02K96-10 (Lot serial: 403142); Model Catalog: 02K96-02 (Lot serial: 403142)
  • Product Description
    MULTIGENT HEMOGLOBIN A1C CALIBRATORS
  • Manufacturer
    BGP PHARMA ULC

Manufacturer

BGP PHARMA ULC
  • Manufacturer Address
    ETOBICOKE
  • Source
    HC