Events

Recall of Device Recall ARCHITECT LH Reagent

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

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
    36889
  • Event Risk Class
    Class 2
  • Event Number
    Z-0488-2007
  • Event Initiated Date
    2006-11-22
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49522
  • 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 CEP
  • Reason
    The lots of architect lh reagent list 6c25-22, have the potential to generate patient specimen results that are elevated. correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.
  • Action
    Abbott initiated a field correction recall by letter dated 11/22/06 to all customers receiving the affected reagent. The accounts were informed of the elevated patient results with the affected lots of reagents. The accounts were requested to assess the inventory for the affected lots of reagents, discontinue use of the lots and destroy the remaining inventory of the lots, recording the number of kits on the customer reply form and faxing it to Abbott by 12/6/06, indicating that the letter was received and understood. Credit will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.

Device

Device Recall ARCHITECT LH Reagent
  • Model / Serial
    lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
  • Product Description
    ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Manufacturer Address
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA