Events

Recall of Device Recall IMx CA 153 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.

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
    25690
  • Event Risk Class
    Class 2
  • Event Number
    Z-0681-03
  • Event Initiated Date
    2003-03-04
  • Event Date Posted
    2003-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26368
  • 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, Immunological, Antigen, Tumor - Product Code MOI
  • Reason
    The ca 15-3 calibrators may cause depressed values for the ca 15-3 high control and for patient specimens.
  • Action
    Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.

Device

Device Recall IMx CA 153 Reagent Pack
  • Model / Serial
    list 6A75-22, lot 90843M200
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
  • Product Description
    IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL
  • Manufacturer
    Abbott Laboratories HPD/ADD

Manufacturer

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