BEUDAMED
    FDA Recall Terminated

    T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in EDTA human whole blood specimens.

    Recall: Z-2795-2016 · Initiated July 7, 2016

    Recall

    Recall Number
    Z-2795-2016
    Event Number
    74732
    FEI Number
    3010097867
    Product Code
    PII
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 7, 2016
    Terminated
    October 6, 2017
    Address
    T2 Biosystems Inc 101 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in EDTA human whole blood specimens.

    Reason

    Elevated levels of invalid results.

    Action

    Customers were notified of the recall vie e-mail and certified mail on July 7, 2016, with an Urgent Medical Device Recall letter. Customers were asked to take the following actions: 1. Please examine your current inventory and determine whether you have any of the recalled lots listed. (a.) If you DO have cartridges from the recalled lots, please note the quantity of cartridges you have of each lot number on the attached form entitled T2Candida Cartridge Recall Customer Response Form (CRF). Please also immediately quarantine any cartridges from the indicated lots and do not use them. (b.) If you DO NOT have any cartridges from the recalled lots, please also note this in the space provided on the form 2. Send the completed CRF to T2Biosystems via e-mail to [email protected] or via fax to 781-240-0541. Your primary contact at T2 for all recall-related correspondence or questions is Georgette Yannios ([email protected] or 877-504-8282 Option 3). All product will be replaced at no charge to you as soon as possible. 3. Once T2 receives the CRF, we will issue a Return Material Authorization (RMA) number to you along with a FedEx shipping label. After you receive this RMA number and label, please follow the instructions provided with the RMA for shipment of cartridges back to T2 (please do not ship reagent trays as they are not subject to this action).

    Distribution

    Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.

    Quantity

    6,864