Events

Recall of Abbott CellDYN

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
    36567
  • Event Risk Class
    Class 2
  • Event Number
    Z-0246-2007
  • Event Initiated Date
    2006-09-18
  • Event Date Posted
    2006-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48915
  • 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
    in vitro diagnostic - Product Code KRY
  • Reason
    Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (plt) test results.
  • Action
    The firm notified its consignees via customer letter sent on 09/18/2006, with information regarding the recall, requesting reply via a form included in the letter.

Device

Abbott CellDYN
  • Model / Serial
    Lot Numbers: 3098, 3099, 3100
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Costa Rica, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, El Salvador, Germany, Japan, Philippines, Singapore, Hong Kong/China, Taiwan, Thailand, Malaysia, South Korea, Australia, New Zealand, Honduras, Nicaragua, Haiti, Bermuda, Virgin Islands, Panama, St. Eustatius, and St. Martin.
  • Product Description
    Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. || Model numbers: 99120-01
  • Manufacturer
    Abbott Laboratories

Manufacturer

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