Events

Recall of Device Recall Iron Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diagnostic Chemicals, 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
    47475
  • Event Risk Class
    Class 3
  • Event Number
    Z-1327-2009
  • Event Initiated Date
    2008-03-14
  • Event Date Posted
    2009-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69549
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ferrozine Iron Binding Capacity - Product Code JMO
  • Reason
    Precipitate in product may cause elevated background absorbance interference.
  • Action
    Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.

Device

Device Recall Iron Assay
  • Model / Serial
    Lot Number: 33361 Exp: October 2010
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Diagnostics Chemical Limited Iron Assay || Catalog Number: 102-25 || For the In Vitro quantitative determination of iron in serum.
  • Manufacturer
    Diagnostic Chemicals, Ltd.

Manufacturer

Diagnostic Chemicals, Ltd.
  • Manufacturer Address
    Diagnostic Chemicals, Ltd., 16 McCarville Street, Charlottetown Canada Prince Edward Island
  • Source
    USFDA