Events

Recall of COULTER GEN*S SLIDESTAINER

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
    149508
  • Event Risk Class
    II
  • Event Initiated Date
    2010-02-17
  • 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
    Beckman coulter has identified the following four (4) issues with the products: issue 1:there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #@[]`{|}~ are substituted or omitted in other languages. the issue affects the gens lh750 lh780 lh500 and dxh 800. issue 2:independent of language the dxh 800 omits the characters *?" when used as part of the selected demographics including specimen id and patient id. issue 3:in the dxh 800 space(s) used as leading character(s) in a patient or specimen id can cause random insertion of extra character(s) within that identifier. issue 4:the lh500 instrument omits the tilde character (~) from the barcode when read by the primary mode (automatic aspiration) scanner.

Device

COULTER GEN*S SLIDESTAINER
  • Model / Serial
    Model Catalog: 6605470 (Lot serial: ALL); Model Catalog: 6605681 (Lot serial: ALL); Model Catalog: 178833 (Lot serial: ALL); Model Catalog: 6605360 (Lot serial: ALL); Model Catalog: 629029 (Lot serial: ALL); Model Catalog: 723585 (Lot serial: ALL); Model Catalog: 6605632 (Lot serial: ALL)
  • Product Description
    COULTER GEN*S SLIDESTAINER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.