BEUDAMED
    FDA Recall Terminated

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

    Recall: Z-1500-2020 · Initiated November 6, 2019

    Recall

    Recall Number
    Z-1500-2020
    Event Number
    84909
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    DHR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 6, 2019
    Terminated
    September 8, 2022
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

    Reason

    It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.

    Action

    It has been identified that the Rheumatoid Factor calibrator values, for LK151.S.A lot 428217, over recover in comparison to the reference material RF serum, NIBSC. To address this, the calibrator concentration values for the calibrators (SC151.A - E lot 448765) supplied in this kit have been adjusted to align more closely with the reference material. Due to the adjustment of the calibrator values, users may observe a decrease of approximately 21% in patient results in comparison to results obtained using previous calibrator values. In the absence of adopting these changes identified in the field safety notice, there is a risk, when using the affected kit, of reporting falsely abnormal results which may lead to unnecessary additional serological testing. The recalling firm issued a field safety notice along with an e-back form via email to the firm's US agent in CA on 11/6/2019. The US agent was instructed to send the field safety notice and e-back form to its customer via email. The field safety notice issued provides affected customers with reassigned calibrator values as well as a reassigned target and acceptance range for the quality controls provided with kit lot 428217 of LK151.S.A. The FSN instructs customers to input the adjusted values into the assay parameters on the SPAPLUS instrument instead of those supplied on the QC certificate.

    Distribution

    Distributed in CA.

    Quantity

    30 kits