Events

Recall of UNICEL DXC 860I SYNCHRON ACCESS CLINICAL ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    58282
  • Event Risk Class
    III
  • Event Initiated Date
    2009-11-04
  • 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
    The access 1.0 ml insert cup used on unicel dxc synchron clinical systems might be the cause of some sample wheel motion errors when run using 13x100 sample tubes.

Device

UNICEL DXC 860I SYNCHRON ACCESS CLINICAL ANALYZER
  • Model / Serial
    Model Catalog: 4773 (Lot serial: CUP LOT NUMBERS STARTING WITH); Model Catalog: 4772 (Lot serial: "09" OR LATER); Model Catalog: 4773 (Lot serial: "09" OR LATER); Model Catalog: 4772 (Lot serial: CUP LOT NUMBERS STARTING WITH); Model Catalog: 4767 (Lot serial: CUP LOT NUMBERS STARTING WITH); Model Catalog: 4767 (Lot serial: "09" OR LATER); Model Catalog: 4771 (Lot serial: "09" OR LATER); Model Catalog: 4771 (Lot serial: CUP LOT NUMBERS STARTING WITH); Model Catalog: 4768 (Lot serial: "09" OR LATER); Model Catalog: 4768 (Lot serial: CUP LOT NUMBERS STARTING WITH)
  • Product Description
    UNICEL DXC860I SYNC.ACC.CLIN. ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.