BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.

    Recall: Z-1891-2010 · Initiated May 15, 2009

    Recall

    Recall Number
    Z-1891-2010
    Event Number
    52206
    Firm
    Siemens Healthcare Diagnostics Inc.
    FEI Number
    3005250747
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 15, 2009
    Posted
    June 24, 2010
    Terminated
    January 18, 2011
    Address
    5700 W 96th St, Los Angeles, CA, 90045-5544

    Description

    IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.

    Reason

    These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.

    Action

    An Urgent Field Safety Notice dated May 2009 was sent to consignees of record for the previously mentioned lots. The Notice advised the following: These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods. Actions If you are using one of these lots with your instrument, please take the following actions: 1. Upon receipt of a non-affected substrate lot, discontinue using IMMULITE 2000/2500 Chemiluminescent Substrate. Prior to receiving a non-affected substrate lot, you can continue to use the affected substrate if you follow the Interim Procedure. 2. Discard all bottles of the affected Substrate lots remaining in your inventory once non-affected Substrate lots are available. 3. The first time ONLY that you switch from one of the affected substrate lots in Table 1 to a non-affected lot, you should follow the procedure and steps below during instrument Startup: a. Empty the substrate reservoir completely before adding the new lot. b. Prime the instrument to cleanse the lines of the previous lot of substrate. c. Add the new lot of substrate to the reservoir and prime the instrument again.* d. Adjust all methods run on that instrument. *Note: Prime the substrate line as instructed on Page 83, Priming the Substrate Probe, of the IMMULITE 2000/2500 Operators Manual Rev. A. 4. Discuss the contents of this letter with your laboratory director. 5. Complete the Completion Notification Form that accompanies this notice and return it as directed on the form. Submitting this form indicates that you have received the information in the Urgent Field Safety Notice and have either discarded all lots of the affected IMMULITE 2000/2500 Substrate, or are following the Interim Procedure while awaiting the receipt of a non-affected Substrate lot and will discard the affected lots as soon as the non-affected lots are received in your laboratory. Interim Procedure Siemens recognizes that you

    Distribution

    Nationwide Distribution

    Quantity

    41,573