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
    110303
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-17
  • 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
    Customers have observed that the differential results for coulter 5c abnormal ii cell control recovered an excessive number of incomplete computation (.....) and/or review ("r") flags on teh coulter lh 500 series and hmx analyzers. the issue may occur more often when laboratory temperatures fall below 70 degrees farenheit (21 degrees celsius).

Device

COULTER LH 500 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 178833 (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 6605526 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6605523 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    COULTER LH 500 SERIES SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.