An internal investigation was performed for a customer in france reporting invalid calibration and s1 results associated with vidas® fsh (lot 1006080890).Tests performed during the in-house investigation, confirmed a decrease of the s1 signal for multiple lots.Cross-testing between vidas fsh assay strips and the solid phase receptacle (spr) demonstrated that the decrease of signal was related to the strips.The investigation has identified the exact well of the strip leading to the calibration issue.Furthermore, the root cause was linked to multiple lots of a raw material (horse serum) containing specific interfering antibodies.Field safety corrective action (fsca) 3834 was issued on 07mar2018 for vidas fsh lot 1006080890, instructing customers to destroy the impacted lot.A capa (corrective action preventive action) is ongoing to implement corrective and/or preventive actions.
|