Events

Recall of AEROSET Phenobarbital, LN 1E08-01

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
    27684
  • Event Risk Class
    Class 2
  • Event Number
    Z-0208-04
  • Event Initiated Date
    2003-11-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30333
  • 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
    Fluorescence Polarization Immunoassay, Phenobarbital - Product Code LGQ
  • Reason
    Assay is imprecise.
  • Action
    Firm telephoned customers on 11/3/2003 and followed up with a letter offering credit or replacement.

Device

AEROSET Phenobarbital, LN 1E08-01

Manufacturer

Abbott Laboratories Diagnostic Div
  • Manufacturer Address
    Abbott Laboratories Diagnostic Div, 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA