Events

Recall of COULTER LH 500 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
    135614
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-03
  • 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
    Follows recall number 59046 (beckman coulter update letter dated april 20 2011 pca-14994). two additional lots of lh series pak reagent kits were not identified in the last communication. excess r flags and incomplete or abnormal differential computation results with use of coulter 5c cell control abnormal ii may also be encountered with lh series pak reagent kits lots 110882k and 110883k.

Device

COULTER LH 500 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 178833 (Lot serial: ALL); Model Catalog: 178832 (Lot serial: ALL); Model Catalog: A91062 (Lot serial: ALL); Model Catalog: A90994 (Lot serial: ALL); Model Catalog: 178834 (Lot serial: ALL); Model Catalog: 6605525 (Lot serial: ALL); Model Catalog: 6605524 (Lot serial: ALL); Model Catalog: 6605522 (Lot serial: ALL); Model Catalog: 6605526 (Lot serial: ALL); Model Catalog: 6605527 (Lot serial: ALL); Model Catalog: A85564 (Lot serial: ALL); Model Catalog: A85566 (Lot serial: ALL); Model Catalog: 6605523 (Lot serial: ALL); Model Catalog: 6706000 (Lot serial: ALL); Model Catalog: 6705999 (Lot serial: ALL); Model Catalog: 6705998 (Lot serial: ALL); Model Catalog: 6705997 (Lot serial: ALL); Model Catalog: 6705996 (Lot serial: ALL); Model Catalog: 6705995 (Lot serial: ALL); Model Catalog: 6604687 (Lot serial: ALL); Model Catalog: 6604569 (Lot serial: ALL)
  • Product Description
    COULTER LH 500 SERIES ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.