BEUDAMED
    FDA Recall Terminated

    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

    Recall: Z-2077-2018 · Initiated March 5, 2018

    Recall

    Recall Number
    Z-2077-2018
    Event Number
    79813
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 5, 2018
    Terminated
    August 31, 2020
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    Description

    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

    Reason

    Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

    Action

    The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following: *Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa. " For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology. " Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: [email protected] or Regular mail: 3600 Gantz Rd., Grove City, OH 43123. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: [email protected]. Monday - Friday, from 9:00 AM to 5:00 PM (PST).

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

    Quantity

    5293