BEUDAMED
    FDA Recall Terminated

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    Recall: Z-1720-2016 · Initiated April 22, 2016

    Recall

    Recall Number
    Z-1720-2016
    Event Number
    73949
    Firm
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics
    FEI Number
    2250033
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 22, 2016
    Terminated
    December 14, 2016
    Address
    6260 Sequence Dr, San Diego, CA, 92121-4358

    Description

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    Reason

    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

    Action

    Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: [email protected]

    Distribution

    U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.

    Quantity

    135 boxes