Events

Recall of Device Recall AxSYM Quinidine Standard 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
    38167
  • Event Risk Class
    Class 2
  • Event Number
    Z-1185-2007
  • Event Initiated Date
    2007-05-31
  • Event Date Posted
    2007-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53085
  • 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
    Quinidine Standard Calibrators - Product Code LGI
  • Reason
    Controls out of range/specification .
  • Action
    May 31, 2007, Product Correction Letter to Customers were instructed to: "Revise the expiration date for all lots identified in the customer letter. "Discontinue use of the expired lots, and discard the material according to their laboratory procedures. "An additional option is to use the Abbott Immunoassay Multiconstituent Control (List Number 06E20), manufactured by BIO-RAD.

Device

Device Recall AxSYM Quinidine Standard Calibrators
  • Model / Serial
    Lot # 44794Q100 Exp. Date: 08/09/2007 and  Lot # 47093Q100 Exp. Date: 10/10/2007
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
  • Product Description
    AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Manufacturer Address
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA