BEUDAMED
    FDA Recall Terminated

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    Recall: Z-0321-2021 · Initiated October 9, 2020

    Recall

    Recall Number
    Z-0321-2021
    Event Number
    86598
    Firm
    Primus Corporation
    FEI Number
    1931251
    Product Code
    GKA
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    October 9, 2020
    Terminated
    November 4, 2021
    Address
    4231 E 75th Ter, Kansas City, MO, 64132-2059

    Description

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    Reason

    The product did not receive pre-market approval or clearance.

    Action

    Recall letters have been sent to US consignees via Federal Express Priority Overnight delivery. Customers were advised to transition to alternate testing methods and qualify a replacement device by March 7, 2021. During the transition, consumables will be made available for use but must be destroyed upon return of the analyzer. Customers were also instructed to agree to the above requirements and return a Fax Back Form confirming compliance. Follow-up will be conducted with consignees that do not reply to the recall notification.

    Distribution

    US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin OUS - Bahrain, Iran, Malaysia, Saudi Arabia, Taiwan, Turkey, UAE, UK, Vietnam

    Quantity

    97 devices (USA only)