BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0611-05 · Initiated December 21, 2004

    Recall

    Recall Number
    Z-0611-05
    Event Number
    30664
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 21, 2004
    Posted
    March 11, 2005
    Terminated
    June 30, 2005
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

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

    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.

    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.

    Quantity

    630 units