Events

Recall of Abbott

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

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
    25028
  • Event Risk Class
    Class 2
  • Event Number
    Z-0648-03
  • Event Initiated Date
    2002-10-16
  • Event Date Posted
    2003-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25034
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Reason
    Product elicits fluorescent signal interference due to contamination.
  • Action
    On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Device

Abbott
  • Model / Serial
    Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Canada and Puerto Rico.
  • Product Description
    Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System CELL-DYN REAGENT || Model/List Number 01H73-01
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 5440 Patrick Henry Drive, Santa Clara CA 95054
  • Source
    USFDA