Events

Recall of Device Recall Architect AUSAB 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
    37961
  • Event Risk Class
    Class 2
  • Event Number
    Z-1098-2007
  • Event Initiated Date
    2007-05-14
  • Event Date Posted
    2007-07-24
  • 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=52498
  • 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 LOM
  • Reason
    During an internal study, the architect ausab assay was found to read preparations of the who standard up to 53% higher than the who assigned value. this has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.
  • Action
    All ARCHITECT AUSAB U.S. customers will be contacted. New customers will be contacted through a Product Information Letter that will be included in all ARCHITECT AUSAB Reagent Kits until assay is restandardized. All ARCHITECT AUSAB U.S. customers will be contacted. The following communication types were used: Product Correction Letter Customer Reply Form > Product Information Letter to be included in new kits to be distributed. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed to: Please follow their laboratory procedures for evaluation of these results Disregard the automated interpretation of results for low-level reactive samples. A customer reply form will accompany the Product Correction letter. Effectiveness Check Depth: 100% of customers receiving the Product Correction letter. The start date of communication was May 14,2007.

Device

Device Recall Architect AUSAB Calibrators
  • Model / Serial
    LIST # 01L82-10 Lots # 48253Q101 Exp Date 09/26/2007, 48253Q100Exp Date 06/19/2007, 45556Q100 Exp Date 03/14/2007, 45557Q100 Exp Date 01/01/2007, 44595Q100 Exp Date 02/28/2007, and 42586Q100 Exp Date 01/01/2007
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Product Description
    ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
  • 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