Events

Recall of FORMALIN NEUTRAL BUFFERED 10%

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FISHER SCIENTIFIC.

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
    147667
  • Event Risk Class
    II
  • Event Initiated Date
    2008-06-06
  • 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
    There was a complaint that product was not fixing tissues as expected. material was re-tested and found to be off-spec in the assay. the retest value is 3.4% vs a min assay specs of 4%. could impact effectivnes.

Device

FORMALIN NEUTRAL BUFFERED 10%
  • Model / Serial
    Model Catalog: SF-100-20 (Lot serial: LOT 075923); Model Catalog: SF100-4 (Lot serial: LOT 075923)
  • Product Description
    FORMALIN NEUTRAL BUFFERED 10%
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC