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
    51156
  • Event Risk Class
    Class 2
  • Event Number
    Z-2327-2009
  • Event Initiated Date
    2009-02-12
  • Event Date Posted
    2009-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78864
  • 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
    Enzymatic method, creatinine - Product Code JFY
  • Reason
    Labeled with extended expiration date (24 months instead of 18 months).
  • Action
    Genzyme Corp. notified consignees by Letter dated February 12, 2009 via Federal Express. Accounts are requested to discontinue use and discard units. Customers were also asked to complete and sign the Confirmation of Notification the fax to 1-902-628-6504. For further information, contact Genzyme Technical Support at 1-800-565-0265.

Device

Device Recall Diagnostic Chemicals Limited
  • Model / Serial
    Lot number: 32565 Exp March 09.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.
  • Product Description
    DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.
  • Manufacturer
    Diagnostic Chemicals, Ltd.

Manufacturer

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