Recall of Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 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 data.
  • Extra notes in the data
  • Reason
    A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
  • Action
    Own name distributor consignees were notified on or about 1/3/05 via letter dated 12/21/04, and were requested to discontinue shipment of the product, notify all of their customers of the recall and to discard product. Roche consignees were notified via letter dated 12/21/04, requested to notify their customers if they had further distributed the product, and instructed to discard all inventory of product.


  • Model / Serial
    All units. (Sold only outside of the U.S. by Vital in Netherlands).
  • Product Classification
  • Distribution
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Product Description
    Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
  • Manufacturer


  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source