Events

Recall of HISTOPAQUE 1077-1

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIGMA-ALDRICH CANADA CO..

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
    74172
  • Event Risk Class
    III
  • Event Initiated Date
    2009-12-31
  • 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
    This corrective action was to revise the instructions for use to recommend to the end user to sterile filter histopaque prior to use if separated cells will be subsequently cultured or if sterility is a requirement for down stream use of the cells. this action resulted in a recall to notify any recipients of in-vitro diagnostic labelled histopaque batches still within their expiry dates as of november of 2009 of this change to the instructions for use.

Device

HISTOPAQUE 1077-1
  • Model / Serial
    Model Catalog: 10771-500ML (Lot serial: 087K6015); Model Catalog: 10771-6X100ML (Lot serial: 069K6086); Model Catalog: 10771-100ML (Lot serial: 069K6086); Model Catalog: 10771-500ML (Lot serial: 069K6086); Model Catalog: 10771-6X100ML (Lot serial: 047K6015); Model Catalog: 10771-100ML (Lot serial: 047K6015); Model Catalog: 10771-500ML (Lot serial: 047K6015); Model Catalog: 10771-6X100ML (Lot serial: 037K6141); Model Catalog: 10771-100ML (Lot serial: 037K6141); Model Catalog: 10771-500ML (Lot serial: 037K6141); Model Catalog: 10771-6X100ML (Lot serial: 107K6201); Model Catalog: 10771-100ML (Lot serial: 107K6201); Model Catalog: 10771-500ML (Lot serial: 107K6201); Model Catalog: 10771-6X100ML (Lot serial: 088K6035); Model Catalog: 10771-100ML (Lot serial: 088K6035); Model Catalog: 10771-500ML (Lot serial: 088K6035); Model Catalog: 10771-6X100ML (Lot serial: 037K6300); Model Catalog: 10771-100ML (Lot serial: 037K6300); Model Catalog: 10771-500ML (Lot serial: 037K6300); Model Catalog: 10771-6X100ML (Lot serial:
  • Product Description
    HISTOPAQUE 1077-1
  • Manufacturer
    SIGMA-ALDRICH CANADA CO.

Manufacturer

SIGMA-ALDRICH CANADA CO.
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Merck KGaA
  • Source
    HC