Events

Recall of ACL TOP 500 CTS

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
    134948
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-26
  • 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 acl top instrument may generate an atypical bimodal clot curve without a warning or error. this occurrence of bimodal curves leads to erroneous results where a shorter than expected result is generated by the instrument.

Device

ACL TOP 500 CTS
  • Model / Serial
    Model Catalog: 0000280040 (Lot serial: 08010100 to 10061231); Model Catalog: 0000280020 (Lot serial: 03110101 to 1006111); Model Catalog: 0000280000 (Lot serial: 03110101 to 1006111); Model Catalog: 0000280030 (Lot serial: 08120100 to 10020126); Model Catalog: 0000280000 (Lot serial: 08120100 to 10020126); Model Catalog: 0000280020 (Lot serial: 08120100 to 10020126); Model Catalog: 0000280030 (Lot serial: 06020101 to 10030659); Model Catalog: 0000280030 (Lot serial: 03110101 to 1006111); Model Catalog: 0000280020 (Lot serial: 06020101 to 10030659); Model Catalog: 0000280000 (Lot serial: 06020101 to 10030659)
  • Product Description
    ACL TOP 500 CTS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.