Events

Recall of Device Recall StatSpin Express 4 Centrifuge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by StatSpin, Inc., dba Iris Sample Processing.

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
    54365
  • Event Risk Class
    Class 1
  • Event Number
    Z-0807-2010
  • Event Initiated Date
    2010-01-27
  • Event Date Posted
    2010-03-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88336
  • 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
    Centrifuges For Clinical Use - Product Code JQC
  • Reason
    Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
  • Action
    Iris Sample Processing notified distributors by an Urgent Device Recall letter advising of the recall and the defect. Users are to immediately quarantine the affected products and choose between the two options listed in regards to correcting the affected centrifuge. Customers may return the unit or an upgrade kit with instructions will be sent to upgrade the unit. Questions should be directed to Gail Magrath at 800-782-8774 ext. 6123.

Device

Device Recall StatSpin Express 4 Centrifuge
  • Model / Serial
    Serial Numbers: 00100 through 001679.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.
  • Product Description
    StatSpin Express 4 Horizontal Centrifuge || Model # M510. || Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.
  • Manufacturer
    StatSpin, Inc., dba Iris Sample Processing

Manufacturer

StatSpin, Inc., dba Iris Sample Processing
  • Manufacturer Address
    StatSpin, Inc., dba Iris Sample Processing, 60 Glacier Dr, Westwood MA 02090-1800
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA