Events

Recall of Device Recall AxSYM Folate Medium Control Pack

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

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
    27978
  • Event Risk Class
    Class 3
  • Event Number
    Z-0367-04
  • Event Initiated Date
    2003-12-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31084
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code CGN--
  • Reason
    The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
  • Action
    Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.

Device

Device Recall AxSYM Folate Medium Control Pack
  • Model / Serial
    List 3C81-11, lot 01552M100
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.
  • Product Description
    AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA