Events

Recall of Device Recall AxSYM & IMx CA 125 Reagent Packs

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
    27834
  • Event Risk Class
    Class 3
  • Event Number
    Z-0318-04
  • Event Initiated Date
    2003-11-25
  • Event Date Posted
    2004-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30604
  • 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 LTK--
  • Reason
    The ca 125 assay product inserts list the incorrect storage instructions for the ca 125 calibrators and controls, and the product information letter (pi-p) shipped with the products to correct the storage conditions, 69-6349/r2, refers to an outdated control package insert, 39-1642/r3, instead of the current control package insert 34-1047/r4.
  • Action
    Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.

Device

Device Recall AxSYM & IMx CA 125 Reagent Packs
  • Model / Serial
    all lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.
  • Product Description
    AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064
  • 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