Events

Recall of STATSPIN CRITSPIN WITH DIGITAL READER M961-22 CS22

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IRIS DIAGNOSTICS A DIVISION OF IRIS INTERNATIONAL INC..

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
    14734
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    O-ring on rh12 rotor assembly (pn:x00-002227-001) rev b and rev ba used on the statspin centrifuges may dislodge during operation and lead to a possible sample loss.

Device

STATSPIN CRITSPIN WITH DIGITAL READER M961-22 CS22
  • Model / Serial
    Model Catalog: M961-22 (Lot serial: all lots. contact mfg); Model Catalog: V901-22 (Lot serial: all lots. contact mfg); Model Catalog: M901-22 (Lot serial: all lots. contact mfg)
  • Product Description
    StatSpin CritSpin with digital reader
  • Manufacturer
    IRIS DIAGNOSTICS A DIVISION OF IRIS INTERNATIONAL INC.

Manufacturer

IRIS DIAGNOSTICS A DIVISION OF IRIS INTERNATIONAL INC.