BEUDAMED
    FDA Recall Terminated

    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

    Recall: Z-0477-2019 · Initiated July 25, 2018

    Recall

    Recall Number
    Z-0477-2019
    Event Number
    81409
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    CFN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 25, 2018
    Posted
    November 17, 2018
    Terminated
    April 27, 2021
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

    Reason

    After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

    Action

    On 07/25/2018, the Urgent Field Safety Notice and Field Correction E-back Form were emailed to customers. Customers were advised to cease use of the affected product and to dispose of the kits locally. This notice states that a witness signature of kit disposal is required on the E-back form. This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. Customers with additional questions are encouraged to contact their local firm representative, or customer service via phone at +44(0) 1214569696, or email at [email protected]. The E-back Form requests that each customer and witness sign and date confirming they have both received and have followed the advice issued in the Notification. It also asks for the number of product in stock and number of kits disposed.

    Distribution

    U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA

    Quantity

    108