Events

Recall of MICROSCAN 10% FERRIC CHLORIDE

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

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
    25575
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-19
  • 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 siemens healthcare diagnostics investigation has confirmed b1015-48 microscan 10% ferric chloride smn 10444551 lot 2014-03-26 a portion of the 10% ferric chloride reagent bottle labels were printed with an incorrect lot/expiration of 2015-03-26 instead of 2014-03-26. the incorrect lot number was found randomly through-out the lot. the effect is the potential for using this lot of 10% ferric chloride reagent past the correct expiration dating of 2014-03-26. there is no health risk with the product since this 10% ferric chloride reagent lot is still within the expiration dating of 2014-03-26. therefore it is not necessary for the customer to review previous test results or to repeat testing.

Device

MICROSCAN 10% FERRIC CHLORIDE
  • Model / Serial
    Model Catalog: B1015-48 (Lot serial: 2014-03-26)
  • Product Description
    MICROSCAN 10% FERRIC CHLORIDE
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC