Events

Recall of Aeroset Direct HDL Reagent, LN 7D67-01

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories Diagnostic Div.

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
    25990
  • Event Risk Class
    Class 3
  • Event Number
    Z-0803-03
  • Event Initiated Date
    2003-03-28
  • Event Date Posted
    2003-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26834
  • 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
  • Reason
    Degredation prior to expiry date.
  • Action
    Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.

Device

Aeroset Direct HDL Reagent, LN 7D67-01
  • Model / Serial
    Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.
  • Product Description
    Aeroset Direct HDL Reagent, LN 7D67-01
  • Manufacturer
    Abbott Laboratories Diagnostic Div

Manufacturer

Abbott Laboratories Diagnostic Div
  • Manufacturer Address
    Abbott Laboratories Diagnostic Div, 820 Mission Street, South Pasadena CA 91030
  • Source
    USFDA