Events

Recall of Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA.

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
    56775
  • Event Risk Class
    Class 2
  • Event Number
    Z-0489-2011
  • Event Initiated Date
    2010-07-23
  • Event Date Posted
    2010-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94516
  • 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
    The vent needle, which is built into the vent head assembly on the cell-dyn sapphire instrument and which is used directly on the cell-dyn 4000 instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.
  • Action
    Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall.

Device

Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly
  • Model / Serial
    Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
  • Product Description
    CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; || CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, || CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, || CELL-DYN 4000 Vent Needle, List Number: 02H61-01, || CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, || CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, || CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, || CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; || Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
  • Manufacturer
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

Manufacturer

Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Manufacturer Address
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA