BEUDAMED
    FDA Recall Terminated

    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

    Recall: Z-0003-2007 · Initiated November 11, 2005

    Recall

    Recall Number
    Z-0003-2007
    Event Number
    36018
    FEI Number
    3002808140
    Product Code
    NHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2005
    Posted
    October 3, 2006
    Terminated
    March 3, 2007
    Address
    Axis-Shield Diagnostics, Ltd. The Technology Park Luna Place Dundee, Scotland United Kingdom

    Description

    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

    Reason

    The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.

    Action

    Advisory letter was sent to customers informing them of the increased sodium azide content. A specific letter was sent to each customer / distributor informing them of the misformulation. The content of the letter referred to the specific kits received by each customer. The letter informed users about the additional risk relating to double azide concentration. The outcome of the risk evaluation was as follows: 1) There is no impact to product performance and hence patient results because of this. 2) The increase in the sodium azide concentration changes the hazard status from ''No significant hazard'' to ''Harmful'', with the following additional risk phrases R22 (harmful if swallowed) and R32 (contact with acids liberates toxic gas). The accompanying safety phrases are S23 (do not breathe fumes), S26 (in case of contact with eyes, rinse immediately with plenty of water and seek medical advice), S46 (if swallowed, seek medical advice immediately and show this container or label) and S61 (avoid release to environment, refer to special instructions/safety data sheets). 3) The risk of the increase in sodium azide concentration in the Kit Negative Conrol to the end user is deemed to be minimal due to the low volume of the Negative Control. The letter states that the product can still be safely used and users should be aware of and take notice of the advisory letter.

    Distribution

    Worldwide distribution ---- USA including states of MN, CA, NJ, WA, IL, CO,and NY and countries of Canada, Spain, Bulgaria, UK, Lebanon, Russia, Columbia, South Africa, Italy, Sweden, Germany, Norway, Venezuela, Japan, Tunisia, Cyprus, The Netherlands, Greece, Israel, and India.

    Quantity

    2,288 Kits