Events

Recall of Device Recall RTH8 Rotor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Iris Diagnostics.

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
    69946
  • Event Risk Class
    Class 2
  • Event Number
    Z-0857-2015
  • Event Initiated Date
    2014-12-03
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132012
  • 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 (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Reason
    Iris international is recalling the rth8 rotor used in the statspin express 4 horizontal centrifuge because the rth8 rotor may develop cracks with use over time.
  • Action
    A customer notification letter dated 12/3/14 was sent to all customers to inform them that Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time. The letter informs the customers of the problems identified and the actions to be taken. Beckman Coulter will be managing the logistics of the recall notice. Customers with questions are instructed to contact Customer Technical Support at (800) 854-3633 or via website at http://www.beckmancoulter.com.

Device

Device Recall RTH8 Rotor
  • Model / Serial
    Serial No. 3100 through 7012
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.
  • Product Description
    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. || The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
  • Manufacturer
    Iris Diagnostics

Manufacturer

Iris Diagnostics
  • Manufacturer Address
    Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA