Events

Recall of Device Recall AEROSET, ARCHITECTURE C8000 & C16000

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

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
    55700
  • Event Risk Class
    Class 2
  • Event Number
    Z-2398-2010
  • Event Initiated Date
    2010-05-04
  • Event Date Posted
    2010-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91601
  • 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
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • Reason
    Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
  • Action
    Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT cSystems, implement alternative kit sizes without system changes. 7) Provide a copy of the letter to other laboratories that have been distributed the affected product. US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.

Device

Device Recall AEROSET, ARCHITECTURE C8000 & C16000
  • Model / Serial
    Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.
  • Product Description
    Clinical Chemistry Phosphorus assay
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

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