BEUDAMED
    FDA Recall Terminated

    Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.

    Recall: Z-0609-05 · Initiated December 21, 2004

    Recall

    Recall Number
    Z-0609-05
    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

    Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.

    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

    5222 units