Events

Recall of Device Recall IMx Folate Reagent 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
    27835
  • Event Risk Class
    Class 2
  • Event Number
    Z-0293-04
  • Event Initiated Date
    2003-11-23
  • Event Date Posted
    2004-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30609
  • 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
    Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing imx folate testing.
  • Action
    Abbott notified their international affiliates via e-mail on 11/23/03. Important Product Information letters dated 11/24/03 will be sent to the end users by the affiliates, informing them of the possible methotrexate carryover to subsequent samples and falsely elevated folate values.

Device

Device Recall IMx Folate Reagent Pack
  • Model / Serial
    all lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There was no U.S. distribution. The product was internationally distributed through Abbott subsidiaries in Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England and Australia.
  • Product Description
    IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); 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