BEUDAMED
    FDA Recall Terminated

    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

    Recall: Z-2237-2021 · Initiated July 6, 2021

    Recall

    Recall Number
    Z-2237-2021
    Event Number
    88281
    Firm
    Advance Dx, Inc.
    FEI Number
    3006457763
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 6, 2021
    Terminated
    August 22, 2023
    Address
    11250 N 118th Way, Scottsdale, AZ, 85259-4149

    Description

    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

    Reason

    Due to high glucose test results when using the blood collection cards.

    Action

    On 06/15/2021, the firm sent an initial customer notification via email and on 07/06/2021 follow up email was sent with a revised "FOLLOW-UP URGENT: MEDICAL DEVICE RECALL" Letter. The notification was to inform customers that blood collection cards manufactured in 2020 provided inaccurate blood glucose values. Customers are instructed to: 1. If they are conducting blood glucose testing with the affected Blood Collection Card, immediately STOP and review their inventory and remove them from all inventory locations. Recalled products can be identified by the Lot number printed on the products packaging and shipper containers. 2. Pass on this information to anyone who uses or orders Blood Collection Cards at their facility. Additionally, ensure that a copy of this letter is provided to any other organizations to which affected devices have been transferred. 3. Complete the Customer Recall Response Card, scan and email immediately to the email address on the Customer Recall Response Card for product in your facility at the time of receipt of this letter. 4. The Recalling Firm is working to ensure that replacement products are readily available. Once customers have identified how much product they will be returning, call Recalling Firm's Customer Service at 1-847-677-3823 to arrange for product replacement. Any questions concerning this product recall, contact Director of Regulatory Affairs/Quality Assurance at 1-949-433-3058 between 8:00 AM and 5:00 PM Pacific Standard Time, Monday-Friday.

    Distribution

    U.S. Nationwide distribution in the states of MD and NC.

    Quantity

    179,750 cards