Events

Recall of ACT 5DIFF SERIES HEMATOLOGY 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
    30894
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-21
  • 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 confirmed that the serial nameplate attached to rear of the affected devices does not include the nationally recognized testing laboratory (nrtl) certification graphic and therefore the affected devices do not meet the us and canadian occupational safety labeling requirements. this is a labeling error only as the safety of the product has been certified by the nrtl and otherwise meets the us and canadian occupational and safety requirements. the devices therefore are compliant with all ul/csa requirements and received the tuv certificates. the performance of the devices is not impacted.

Device

ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 6605641 (Lot serial: AV07017); Model Catalog: 175356 (Lot serial: AV12038); Model Catalog: 6605641 (Lot serial: AV12038); Model Catalog: 175356 (Lot serial: AV07017); Model Catalog: 175356 (Lot serial: AV05025); Model Catalog: 6605641 (Lot serial: AV14046); Model Catalog: 175356 (Lot serial: AV14046); Model Catalog: 6605641 (Lot serial: AV05025); Model Catalog: 6605641 (Lot serial: AV09024); Model Catalog: 175356 (Lot serial: AV09024)
  • Product Description
    ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.