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
    83900
  • Event Risk Class
    II
  • Event Initiated Date
    2010-12-30
  • 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
    Coulter lyse s iii diff lytic reagent lot number 101554f was released for distribution to customers prior to completion of qc testing. the material failed qc testing for hemoglobin (hgb) and white blood cells (wbc).

Device

COULTER LH 500 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 178833 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 6605360 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 6605632 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 6605122 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 723585 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 6603208 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 6605526 (Lot serial: LYTIC REAGENT 101554F); Model Catalog: 6605523 (Lot serial: LYTIC REAGENT 101554F)
  • Product Description
    COULTER LYSE S III DIFF LYTIC REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.