Events

Recall of Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20

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
    29684
  • Event Risk Class
    Class 2
  • Event Number
    Z-1377-04
  • Event Initiated Date
    2004-07-27
  • Event Date Posted
    2004-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34342
  • 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
    Alkaline Picrate, Colorimetry, Creatinine - Product Code CGX
  • Reason
    Precipitate formed in product.
  • Action
    Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.

Device

Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
  • Model / Serial
    Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
  • Product Description
    Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
  • Manufacturer
    Abbott Laboratories Diagnostic Div

Manufacturer

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