BEUDAMED
    FDA Recall Terminated

    Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family 441104 Electrode Assembly- EL-ISE 445604 Electrode Packaged- EL-ISE

    Recall: Z-0937-05 · Initiated May 20, 2005

    Recall

    Recall Number
    Z-0937-05
    Event Number
    32164
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CEM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 20, 2005
    Posted
    June 28, 2005
    Terminated
    November 21, 2005
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family 441104 Electrode Assembly- EL-ISE 445604 Electrode Packaged- EL-ISE

    Reason

    Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.

    Action

    Firm sent letters by US Mail requesting that users discard thier probes.

    Distribution

    United States and Canada

    Quantity

    2686