Events

Recall of Device Recall TDx/TDxFLx Methotrexate II

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
    37728
  • Event Risk Class
    Class 3
  • Event Number
    Z-1056-2007
  • Event Initiated Date
    2007-03-20
  • Event Date Posted
    2007-07-20
  • 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=51394
  • 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
    Reagent - Product Code LAO
  • Reason
    Incorrect configuration: kits contain reagent bottles in the order s-w-t-p instead of the correct order, w-s-t-p.
  • Action
    The Product Correction Letter dated 3/20/2007, was sent to all customers who received the affected lots. The Customers were instructed to: Determine if they had the lot listed in the Product Correction letter. Inspect each kit of the affected lot and discard any kits incorrectly configured. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them and retain Product Correction letter for their laboratory records.

Device

Device Recall TDx/TDxFLx Methotrexate II
  • Model / Serial
    Lot Number: 45050Q100
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    World wide Distribution : USA including states of AR, CA, CO, CT, DE, FL,GA, ID, IL, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NJ, NY, NC,NV, OH, SC, PA, RI, TN, TX, UT, WA, WI, WV, Hawaii, Washington DC, and Puerto Rico. Countries of : Canada, Mexico, Venezuela, Columbia, Chile, Brazil, Germany, Japan, Hong Kong, Australia and New Zealand
  • Product Description
    TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution.
  • 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