Description of Event or Problem · 0
WE ARE A TESTING AND SCREENING LABORATORY THAT USES QUIDELORTHO PRODUCTS AND INSTRUMENTS FOR DONOR SCREENING OF BLOOD AND PLASMA PRODUCTS. IN (B)(6) WE BEGAN GETTING CONFLICTING TEST RESULTS WHEN PERFORMING PHENOTYPE TESTING FOR JKA/JKB ANTIGENS. WHEN CONTACTING ORTHO, WE WERE INFORMED THAT ALIVEDX WHO IS THE MANUFACTURER OF THEIR PAPAIN REAGENT, REPORTED REDUCED ENZYMATIC ACTIVITY WITH THE LOT BEING USED AND THIS WAS CAUSING THE DISCREPANT RESULTS. WE ISSUED A SCAR TO QUIDELORTHO FOR A DETAILED INVESTIGATION AND CORRECTIVE ACTION PLAN. WE RECEIVED A RESPONSE, BUT THE ROOT CAUSE WAS NOT DETERMINED, AND WE DO NOT FEEL THE ISSUE WAS ADEQUATELY ADDRESSED. THE INITIAL FIELD SAFETY CORRECTIVE ACTION FROM ALIVEDX WAS SENT TO QUIDELORTHO ON (B)(6) 2025, BUT QUIDELORTHO DID NOT SEND NOTIFICATION TO CONSIGNEES UNTIL (B)(6) 2025. GIVEN THE LETHALITY OF NOT IDENTIFYING KIDD ANTIGENS, THIS DELAY IN CONSIGNEE NOTIFICATION WAS UNACCEPTABLE AND NOT EXPLAINED. ALSO, THE TESTING OF RETENTION SAMPLES FROM THE AFFECTED PAPAIN LOT SHOWED UNEXPECTED NEGATIVE REACTIONS AND IF THIS TESTING HAD BEEN DONE ON THE RAW MATERIAL PRIOR TO MANUFACTURING THE KIDD REAGENT, THEN THE ISSUE WOULD HAVE BEEN PREVENTED HOWEVER QUIDELORTHO ELECTED NOT TO IMPLEMENT ANY PREVENTATIVE ACTIONS ON FUTURE RAW MATERIAL LOTS. WE REPORTED THIS INCIDENT AS A BPDR AND SENT RECALL NOTIFICATIONS TO OUR CONSIGNEES. QUIDELORTHO NOTIFIED US THAT ALIVEDX ALSO REPORTED THIS TO THE FDA. AS AN END-USER AND CUSTOMER, WE JUST WANT TO MAKE THE FDA IS AWARE THAT EVENTS LIKE THESE COULD CAUSE SERIOUS HARM TO PATIENTS AND ENSURE YOU HAVE BEEN APPRISED OF OUR CONCERNS.