Events

Recall of BC-3600 AUTO HEMATOLOGY ANALYZER - M-30D DILUENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD..

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
    33616
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-28
  • 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
    There is a potential issue with the m-30d diluent used with the bc-3200 and bc-3600 hematology analyzers. use of the affected diluent may cause the system to produce an elevated platlet (plt) background count.

Device

BC-3600 AUTO HEMATOLOGY ANALYZER - M-30D DILUENT
  • Model / Serial
    Model Catalog: 105-005405-00 (Lot serial: Contact manufacturer.); Model Catalog: 105-005406-00 (Lot serial: Contact manufacturer.); Model Catalog: 105-005405-00 (Lot serial: >10 lot numbers.); Model Catalog: 105-005406-00 (Lot serial: >10 lot numbers.)
  • Product Description
    BC-3600 Auto Hematology Analyzer- M-30D Diluent;BC-3200 Auto Hematology Analyzer - Diluent M-30D
  • Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

Manufacturer

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.