Events

Recall of Device Recall Architect Free T4 MasterCheck

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

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
    47236
  • Event Risk Class
    Class 3
  • Event Number
    Z-1569-2008
  • Event Initiated Date
    2008-02-27
  • Event Date Posted
    2008-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69081
  • 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
    Analyte control - Product Code JJX
  • Reason
    Testing material becomes unstable at the recommeded storage temperature. some of the architect free t4 mastercheck and total t4 mastercheck lots are not stable at the recommended storage condition of 2 to 8 degrees celsius through expiration dating. these lots may exceed the suggested tolerance limits listed in the reportable range/calibration verification section in appendix b of the architect.
  • Action
    Abbott sent a Product Recall letter dated 2/27/08, to all customers who received the affected product lots, informing them that the storage conditions are being changed to -10 degrees C or colder for all lots of material manufactured after lot numbers 82130M and 84110M until the cause has been determined and a corrective action has been implemented. All new shipments will contain additional instructions indicating that the ARCHITECT Free T4 and Total T4 MasterChecks are to be stored frozen until first use. Customers were requested to check their inventory for lot numbers 82130M and 84110M, discontinue use of the lots and destroy any remaining inventory. For lots 82140M, 82150M and 84120M, if they know the date the lot was received or the date it was thawed, they may continue to use lots if they have been stored at 2 to 8 degrees C unopened for less than 60 days. If the material has been stored at 2 to 8 degrees C for greater than 60 days or they do not know the number of days it has been thawed, they were instructed to discard the material. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. Customers outside of the U.S., were requested to contact their local customer support representative.

Device

Device Recall Architect Free T4 MasterCheck
  • Model / Serial
    lots 82130M, Exp 06/30/2008; 82140M, Exp 10/31/2008; and 82150M, Exp 12/31/2008
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of Puerto Rico and country of Canada.
  • Product Description
    Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. || Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. || Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA