Events

Recall of Diagnostic Chemicals Limited

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
    36864
  • Event Risk Class
    Class 3
  • Event Number
    Z-0536-2007
  • Event Initiated Date
    2006-09-06
  • Event Date Posted
    2007-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49471
  • 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
    in vitro diagnostic - Product Code JIX
  • Reason
    Microalbumin multi calibrator mislabeled label on level 5 and level 6, cap label correct.
  • Action
    Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.

Device

Diagnostic Chemicals Limited

Manufacturer

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