Events

Recall of Device Recall 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
    37011
  • Event Risk Class
    Class 2
  • Event Number
    Z-0361-2007
  • Event Initiated Date
    2006-12-05
  • Event Date Posted
    2007-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49757
  • 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 DKJ
  • Reason
    Upon subsequent testing on different instruments (as required by other customers), dcl detected a non-linear response on certain analyzers. a decision was made to recall the product due to the fact that dcl customers sell the product to different end users, dcl cannot be certain which instruments the end users employ in their laboratories.
  • Action
    For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits.

Device

Device Recall Diagnostic Chemicals Limited

Manufacturer

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