Events

Recall of Device Recall CELLDYN 3/4/8 Assay reagents for Sapphire

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
    34395
  • Event Risk Class
    Class 2
  • Event Number
    Z-0527-06
  • Event Initiated Date
    2005-12-16
  • Event Date Posted
    2006-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43773
  • 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
    T-cell test results and the respective absolute counts for the cell-dyn sapphire instrument using cd3/4/8 reagents can be overestimated by as much as 13%.
  • Action
    The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.

Device

Device Recall CELLDYN 3/4/8 Assay reagents for Sapphire
  • Model / Serial
    List Number: 07H22-01, lot numbers: 16328 and 29401
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
  • Product Description
    CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
  • Manufacturer
    Abbott Laboratories

Manufacturer

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