Events

Recall of BOND MAX SYSTEM - POLYMER REFINE RED DETECTION

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

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
    16136
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-31
  • 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
    A contaminant fungas of the polymer ap was found during an internal qc testing. the fungal contaminant could potentially cause a loss of staining sensitivity and/or an obstruction to fluid delivery to the slide.

Device

BOND MAX SYSTEM - POLYMER REFINE RED DETECTION
  • Model / Serial
    Model Catalog: DS9390 (Lot serial: 22541); Model Catalog: DS9390 (Lot serial: 22514); Model Catalog: DS9390 (Lot serial: 22411); Model Catalog: DS9390 (Lot serial: 22337); Model Catalog: DS9390 (Lot serial: 22262); Model Catalog: DS9390 (Lot serial: 22139); Model Catalog: DS9390 (Lot serial: 22017)
  • Product Description
    BOND MAX SYSTEM RED DETECTION
  • Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.

Manufacturer

LEICA BIOSYSTEMS NEWCASTLE LTD.
  • Manufacturer Address
    NEWCASTLE UPON TYNE
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    HC