Events

Recall of ASP6025 TISSUE PROCESSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA BIOSYSTEMS NUSSLOCH GMBH.

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
    19501
  • Event Risk Class
    III
  • Event Initiated Date
    2015-08-10
  • 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
    One complaint was received from a customer in spain where poor processing was identified and samples were deemed non-diagnosable. the investigation of the unit when returned to the manufacturer on july 15th led to a safety meeting which determined that the instrument is incorrectly getting into a state of "bottle empty" during retort filling after passing the fill lever sensor 2 and prior to reaching level sensor 3 thus not completing a 5 litre fill.

Device

ASP6025 TISSUE PROCESSOR
  • Model / Serial
    Model Catalog: ASP6025 (Lot serial: 316); Model Catalog: ASP6025 (Lot serial: 448); Model Catalog: ASP6025 (Lot serial: 538); Model Catalog: ASP6025 (Lot serial: 594); Model Catalog: ASP6025 (Lot serial: 446); Model Catalog: ASP6025 (Lot serial: 622); Model Catalog: ASP6025 (Lot serial: 314)
  • Product Description
    LEICA ASP6025 TISSUE PROCESSOR
  • Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH

Manufacturer

LEICA BIOSYSTEMS NUSSLOCH GMBH