BEUDAMED
    FDA Recall Terminated

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    Recall: Z-1790-2014 · Initiated May 21, 2014

    Recall

    Recall Number
    Z-1790-2014
    Event Number
    68294
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 21, 2014
    Posted
    June 14, 2014
    Terminated
    June 4, 2015
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    Reason

    Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

    Action

    Roche sent an Urgent Medical Device Correction (UMDC) letter dated May 20, 2014 via UPS Grount (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Follow the instructions in the Precautions Regarding Handling the Aspiration Tube Filter section in this UMDC; 2. Discontinue performing ProCell/Clean Cell aspiration tube filter check as this maintenance item will be performed by your Roche FSR as a part of service maintenance; 3. If you have distributed the products listed within this UMDC to other sites or facilities, please provide them with a copy of the UMDC; and 4. Complete the faxback form enclosed with this UMDC and fax it to 1-888-410-6620. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

    Distribution

    US Nationwide Distribution

    Quantity

    462