Events

Recall of UNICEL DXI 600 ACCESS IMMUNOASSAY SYS - INSTRUMENT W/ DUAL GANTRY CLASS 2

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
    145919
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-19
  • 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
    Beckman coulter has determined that nonconforming sample probe cables may have been installed on newly manufactured and/or recently serviced unicel dxi instruments. use of a nonconforming sample probe cable can cause a delay in reporting results but will not cause erroneous results. a nonconforming sample probe cable may cause level sense errors. if a level sense error occurs due to a nonconforming cable the test may not start or an in-process test is automatically cancelled.

Device

UNICEL DXI 600 ACCESS IMMUNOASSAY SYS - INSTRUMENT W/ DUAL GANTRY CLASS 2
  • Model / Serial
    Model Catalog: A71461 (Lot serial: 900359); Model Catalog: 973100 (Lot serial: 601704); Model Catalog: 973100 (Lot serial: 600785); Model Catalog: 973100 (Lot serial: 601257); Model Catalog: 973100 (Lot serial: 600968); Model Catalog: 4771 (Lot serial: 900950); Model Catalog: 4771 (Lot serial: 900613); Model Catalog: A30260 (Lot serial: 900613); Model Catalog: A30260 (Lot serial: 900950); Model Catalog: 4768 (Lot serial: 601704); Model Catalog: 4768 (Lot serial: 600785); Model Catalog: 4768 (Lot serial: 601257); Model Catalog: 4768 (Lot serial: 600968); Model Catalog: 4772 (Lot serial: 900613); Model Catalog: 4773 (Lot serial: 601257); Model Catalog: 4773 (Lot serial: 600785); Model Catalog: 4772 (Lot serial: 900950); Model Catalog: 4773 (Lot serial: 600968); Model Catalog: 4773 (Lot serial: 601704)
  • Product Description
    UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEMS (DL 75053)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.