Events

Recall of Genzyme

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genzyme Corporation.

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
    48184
  • Event Risk Class
    Class 3
  • Event Number
    Z-2149-2008
  • Event Initiated Date
    2008-04-14
  • Event Date Posted
    2008-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71385
  • 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
    Lipase - Product Code CHI
  • Reason
    Calibration and quality control outside of established range resulting from an increase in initial od readings with the reagent contained within the kits.
  • Action
    Genzyme notified accounts by Fed'X on 4/14/08 via an Imprtant Field Correction letter, requesting users to discard kits and follow the "User Update" instructions previously provided to minimize calibration error. Customers are to complere and sign the Confirmation of Notification form and fax it back to the firm regardless if they have any affected product or not. Also, requires that the customer confirms that the REagent OD limits for First and Last H are set at 0.15 for Lipase on the Olympus AU400/400e, AU600, AU640/640e and AU2700/AU5400 Systems.

Device

Genzyme
  • Model / Serial
    Reagent lot Number 491686, Lot #7EPN32 Exp 01/15/09
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-C || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
  • Manufacturer
    Genzyme Corporation

Manufacturer

Genzyme Corporation
  • Manufacturer Address
    Genzyme Corporation, 500 Kendall Street & 1 Kendall Square, Cambridge MA 02139
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA