Events

Recall of Device Recall CELLDYN Sheer Valve Assembly Driver

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
    58188
  • Event Risk Class
    Class 2
  • Event Number
    Z-2020-2011
  • Event Initiated Date
    2011-03-15
  • Event Date Posted
    2011-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98629
  • 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
    Differential Cell Counter - Product Code GKZ
  • Reason
    The nylon washer has an outer diameter which is undersized resulting in the inability to generate patient results.
  • Action
    Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.

Device

Device Recall CELLDYN Sheer Valve Assembly Driver
  • Model / Serial
    List Number 8921204902:  Date Code 20-Jan-2011 Pallet ID 48312339; Date Code 08-Feb-2011 Pallett ID 95795162.  List Number 8921167602: Date Code 13-Dec-2010 Pallet ID 80671954; Date Code 15-Dec-2010 Pallet ID 32777397; Date Code 16-Dec-2010 Pallet ID 46425128; Date Code 18-Jan-2011 Pallet ID 42387574; and Date Code 20-Jan-2011 Pallet ID 35758457.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
  • Product Description
    CELL-DYN Sheer Valve Assembly Driver || Abbott Diagnostics Division, Santa Clara, CA 05054
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA