Recall Z-0604-2019

Reason for recall

Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

FDA-determined cause: Under Investigation by firm

Action taken

On 11/06/2018, the firm, The Binding Site, emailed an "Urgent Medical Device Correction notice" and Field Correction E-back Form to customers. The notice described the product, problem and actions to be taken. Customers were instructed to do the following: 1) Reagents are to be loaded on-board the analyser and left for a minimum of 18 hours prior to running the calibration and validating the curve. Please leave the reagents on-board the analyser until empty. 2) Once calibration is established and validated, reagents must remain on the instrument until the reagent has been fully consumed. 3) When not in use the control vials and calibrator sets should be removed from the instrument, be capped to avoid evaporation and stored at 2-8 degrees C. 4) To be able to accept the calibration curve and to use the assay to report test results, the control materials to be tested at a minimum once a day should return results within 15% of the concentration(s) as stated on the accompanying QC certificate. If a control measurement is out of range when assayed with a stored curve the assay must be recalibrated. If on recalibration the control values measured with the new curve are still out of range, the instrument and the assay parameters should be checked before repeating the assay. 5) If calibration issues are still experienced when following this advice please do not hesitate to contact a firm representative. The E-back Form requests that each customer sign the form confirming they have both received and have followed the advice issued in the Notification; and return completed E-back form to technical.support@bindingsite.com or your local Binding Site Representative. This notice needs to be passed on 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 phon