Events

Recall of BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM (DONOR SCREENING) - CMV-PA TEST

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
    21177
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-01
  • 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
    Pk cmv-pa reactive and non-reactive control vials from affected lots may contain lint. presence of lint in the control tubes has the potential to interfere with photometry and the controls may not test as expected and necessitate the run be repeated. donor results are not impacted by this issue.

Device

BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM (DONOR SCREENING) - CMV-PA TEST
  • Model / Serial
    Model Catalog: PA2302 (Lot serial: 309069); Model Catalog: PA2302 (Lot serial: 309048)
  • Product Description
    PK CMV-PA CONTROL SET
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.