Events

Recall of Device Recall Genzyme Diagnostics Total Serum Cholesterol Kit,

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
    57230
  • Event Risk Class
    Class 3
  • Event Number
    Z-0711-2011
  • Event Initiated Date
    2010-11-10
  • Event Date Posted
    2010-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95633
  • 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 esterase--oxidase, cholestrol - Product Code CHH
  • Reason
    Cholesterol reagent bottles labels reversed for r1 and r2.
  • Action
    Genzyme Diagnostics P.E.I. Inc. sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated November 10, 2010, via Federal Express to customers. The letter described the label error and requested that the reagents not be interchanged with another reagent lot. The firm ask that the customers complete and return the attached IMPORTANT PRODUCT FIELD CORRECTION confirmation of notification via fax at 902-628-6504. Contact a Genzyme Diagnostics Technical Services Representative at 1-800- 565-0265, if you require further information, or if you have any questions.

Device

Device Recall Genzyme Diagnostics Total Serum Cholesterol Kit,
  • Model / Serial
    Lot 37772  Exp. Date: May 2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.
  • Product Description
    Genzyme Diagnostics Total Serum Cholesterol Kit, IVD || Catalog Number: 225-26 || Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.
  • Manufacturer
    Diagnostic Chemicals, Ltd.

Manufacturer

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