Events

Recall of Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer

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
    46368
  • Event Risk Class
    Class 2
  • Event Number
    Z-1165-2008
  • Event Initiated Date
    2008-01-15
  • Event Date Posted
    2008-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67306
  • 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
    Count may be out of specification--hemoglobin background count may be out of specification (high) after installation of new cell-dyn sapphire hemoglobin reagent syringes with packaging dates between may 8, 2007 and november 29, 2007.
  • Action
    On January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.

Device

Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer
  • Model / Serial
    All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8,2007 and November 29,2007. Each package is identified with product description "CDS HGB SRNG W/BU".
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.
  • Product Description
    CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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