Events

Recall of Device Recall AxSYM Ultrasensitive hTSH II Master 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
    47203
  • Event Risk Class
    Class 2
  • Event Number
    Z-1566-2008
  • Event Initiated Date
    2008-03-06
  • Event Date Posted
    2008-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69028
  • 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
    Calibrator - Product Code JIS
  • Reason
    High control value out of range after calibration. --an increased frequency of high control values beyond the upper limit of the range specified by the package insert.
  • Action
    The firm issued Product Recall letters dated February 22, 2008, requesting remaining units of the affected product be discontinue using and destroyed. A Customer Reply Immediate Action Required letter was enclosed to indicate acknowledging receipt of the product recall letter and to provide information on the number of kits destroyed before March 7, 2008 and faxed to 1-800-777-0051.

Device

Device Recall AxSYM Ultrasensitive hTSH II Master Calibrators
  • Model / Serial
    Lot 50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot # 53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date 09/07/2008
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.
  • Product Description
    AxSYM Ultrasensitive hTSH II Master Calibrators || Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
  • 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