Events

Recall of ASP 300 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
    53292
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-04
  • 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 where the remote alarm of an affected instrument did not alert the customer properly of an error that occurred during processing. a review meeting was held by the manufacturer to determine that the drawing of the remote alarm cable does have an error which led to a malfunction of the remote alarm. cables with this error were used since april 24 2013 in production. a shiphold of the asp200s/asp300s was initiated on july 13 2015. within this time period 901 instruments were distributed globally with the affected cables. the affected devices have an incorrect internal wiring to the remote alarm plug which can cause the remote alarm to not function correctly in the case of an instrument failure.

Device

ASP 300 TISSUE PROCESSOR
  • Model / Serial
    Model Catalog: ASP300S (Lot serial: 5818); Model Catalog: ASP200S (Lot serial: 5818); Model Catalog: ASP300S (Lot serial: 5687); Model Catalog: ASP200S (Lot serial: 5687); Model Catalog: ASP300S (Lot serial: 5686); Model Catalog: ASP200S (Lot serial: 5686); Model Catalog: ASP300S (Lot serial: 5685); Model Catalog: ASP200S (Lot serial: 5685); Model Catalog: ASP300S (Lot serial: 5618); Model Catalog: ASP200S (Lot serial: 5618); Model Catalog: ASP300S (Lot serial: 5593); Model Catalog: ASP200S (Lot serial: 5593); Model Catalog: ASP300S (Lot serial: 5541); Model Catalog: ASP200S (Lot serial: 5541)
  • Product Description
    ASP200S/ASP300S TISSUE PROCESSOR
  • Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH

Manufacturer

LEICA BIOSYSTEMS NUSSLOCH GMBH