Events

Recall of Device Recall ARCHITECT Ferritin Reagent

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

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
    35612
  • Event Risk Class
    Class 3
  • Event Number
    Z-1204-06
  • Event Initiated Date
    2006-06-06
  • Event Date Posted
    2006-07-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46468
  • 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
    Ferritin, Antigen, Antiserum, Control - Product Code DBF
  • Reason
    Some architect ferritin reagent lots may not be meeting the accuracy by correlation to axsym claims as they are listed in the package insert (slope of 1.0 +/- 0.2).
  • Action
    Abbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachment A when they change to the assay materials manufactured using the new internal reference standards. The accounts were requested to keep a copy of the letter on file until the revised package insert is received.

Device

Device Recall ARCHITECT Ferritin Reagent
  • Model / Serial
    list numbers 6C11-20, 6C11-25 and 6C11-30; all lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand
  • Product Description
    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Manufacturer Address
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA