Events

Recall of Clinical Chemistry Uric Acid; LN 7D76-20

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
    28627
  • Event Risk Class
    Class 2
  • Event Number
    Z-0769-04
  • Event Initiated Date
    2004-03-18
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32252
  • 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
    Acid, Uric, Uricase (U.V.) - Product Code CDO
  • Reason
    Unacceptable upward drift of results in control runs within 24 hour period.
  • Action
    Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.

Device

Clinical Chemistry Uric Acid; LN 7D76-20

Manufacturer

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