Events

Recall of FSH Calibrators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Diagnostic International, 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
    36405
  • Event Risk Class
    Class 2
  • Event Number
    Z-0024-2007
  • Event Initiated Date
    2006-09-07
  • Event Date Posted
    2006-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48602
  • 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
    FSH in vitro diagnostic - Product Code JIT
  • Reason
    Following a customer complaint, abbott found an atypical stability profile for the lot of the calibrators listed in this recall. the investigation to date has shown that both controls and patient results have shifted upwards over time together.
  • Action
    The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.

Device

FSH Calibrators
  • Model / Serial
    Lot # 33362Q100 Expiration Date 11/04/2006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.
  • Product Description
    FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Manufacturer Address
    Abbott Diagnostic International, Ltd., Carr 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA