BEUDAMED
    FDA Recall Terminated

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    Recall: Z-1422-2022 · Initiated June 9, 2022

    Recall

    Recall Number
    Z-1422-2022
    Event Number
    90471
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    DDG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 9, 2022
    Terminated
    February 8, 2024

    Description

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    Reason

    A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

    Action

    On June 9, 2022, the firm notified customers of the recall via email. The issue only affects Siemens Atellica CH analyzer users. No action is required if the assay is being run on other platforms. The issue will be resolved in Atellica Solution Software (SW) version 1.25.3. Until all Atellica CH analyzers in the laboratory are updated to SW 1.25.3, the assay can be run by Open Channel. Please contact [email protected] for an Atellica CH Open Channel application sheet. If the assay is not run by Open Channel prior to installation of SW version 1.25.3, the assay must be re-calibrated once 1.25.3 is installed. Customers were instructed to review results generated with the affected batches in line with the clinical profile of the patient.

    Distribution

    US Nationwide distribution in the state of IL.

    Quantity

    12 kits (US)