Events

Recall of Device Recall ARCHITECT CA 199 Reagent Kit

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
    28641
  • Event Risk Class
    Class 2
  • Event Number
    Z-0781-04
  • Event Initiated Date
    2004-03-23
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32275
  • 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
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
  • Reason
    The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
  • Action
    Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.

Device

Device Recall ARCHITECT CA 199 Reagent Kit
  • Model / Serial
    lot numbers 07747M100 and 07747M101
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Australia, Germany and Japan
  • Product Description
    ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
  • 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