Recall of Device Recall CA 153 Calibrator 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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.


  • Model / Serial
    list 9C08-01, lot 88127M100
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
  • Product Description
    CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer


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