ALINITY M HSV 1 & 2 / VZV AMP KIT

Description of Event or Problem

THE CUSTOMER REPORTED 2 FALSE NEGATIVE HSV-1 RESULTS ON THE ALINITY M HSV 1 & 2 / VZV ASSAY. THE CUSTOMER REPORTED THAT SAMPLE ID (SID) (B)(6) (PENILE SWAB) WAS TESTED ON (B)(6) 2025 AND THE RESULT WAS "NOT DETECTED." THIS SAMPLE WAS CHOSEN AT RANDOM FOR REPEATABILITY (INTERNAL QUALITY ASSESSMENT) AND RETESTED (USING THE SAME TUBE) ON (B)(6) 2025 UNDER SID (B)(6). THE RESULT WAS POSITIVE FOR HSV-1. THIS SAMPLE WAS AGAIN RETESTED ON (B)(6) 2025 AND WAS POSITIVE FOR HSV-1. THE CUSTOMER REPORTED THAT THE SAMPLES ARE RECEIVED IN MEDICAL WIRE VIRAL TRANSPORT MEDIUM AND INACTIVATED BY ADDING 1ML OF 'TERMINATOR' MEDIUM. THESE HAVE BEEN VALIDATED AS PART OF THEIR VERIFICATION PROCESS. THEY ARE GENERALLY TESTED THE SAME DAY AS RECEIVED. BETWEEN (B)(6) 2025 AND THE RETESTING DATES, THE SAMPLES HAD BEEN STORED AT AMBIENT TEMPERATURE. THE CLINIC HAD NOTIFIED THE PATIENT ON (B)(6) 2025 OF THE NEGATIVE RESULT AND THEN LATER CONTACTED THEM THE SAME DAY TO INFORM THEM OF THE AMENDED POSITIVE RESULT. THE CUSTOMER EXTENDED THEIR RETESTING AND IDENTIFIED A SECOND FALSE NEGATIVE RESULT. SID (B)(6) WAS TESTED ON (B)(6) 2025 AND THE RESULT WAS "NOT DETECTED." THIS SAMPLE WAS AGAIN RETESTED ON (B)(6) 2025 AND WAS POSITIVE FOR HSV-1. THE CUSTOMER CONTACTED THE CLINIC AND THEY TREATED THE PATIENT CLINICALLY FOR HERPES BASED ON PRESENTATION. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M HSV 1 & 2 / VZV ASSAY, LIST LIST NUMBER 09N61-090, WHICH IS THE SAME/SIMILAR TO THE ALINITY M HSV 1 & 2 / VZV ASSAY, LIST NUMBER 09N61-095, WHICH RECEIVED FDA APPROVAL.

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, RETAIN/FILE SAMPLE REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUN WAS VALID, MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CONTROLS. THE ASSAY IS PERFORMING AS EXPECTED WITH CORRECT INTERPRETATIONS. THERE IS NO INDICATION THAT THE ALINITY M HSV 1 & 2 / VZV AMP KIT (LIST 09N61-090) LOT 409807 IS PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS BASED ON THE ELEMENTS REVIEWED IN THIS SECTION. RETAIN/FILE SAMPLE REVIEW: FILE SAMPLE TESTING WAS PERFORMED. THE ASSAY REAGENTS PERFORMED AS EXPECTED AND MET THE ASSAY SPECIFICATION REQUIREMENTS WITHOUT ANY ERROR/MESSAGE CODES OR PERFORMANCE RELATED FLAGS ON THE RUN CONTROLS. THE RUNS MET ALL VALIDITY AND ACCEPTANCE CRITERIA. A PRODUCT DEFICIENCY COULD NOT BE IDENTIFIED BY THE FILE SAMPLE EVALUATION FOR THE ALINITY M HSV 1 & 2 / VZV AMP KIT (LIST 09N61-090) LOT 409807. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKETS FOR ALINITY M HSV 1 & 2 / VZV AMP KIT (LIST 09N61-090)LOT 409807 (INCLUDING THE COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. ADDITIONALLY, THE QUALITY CONTROL (QC) TESTING FOR THE ALINITY M HSV 1 & 2 / VZV AMP KIT (LIST 09N61-090) LOT 409807 (INCLUDING THE COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW: A CAPA LOT SEARCH WAS PERFORMED TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS WHICH COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. NO EXISTING INTERNAL QUALITY RECORDS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED AS A RESULT OF THIS REVIEW FOR THE REPORTED LOTS. COMPLAINT HISTORY REVIEW A COMPLAINT REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED FOR ALINITY M HSV 1 & 2 / VZV AMP KIT (LIST 09N61-090) LOT 409807. COMPLAINT TRENDING WAS PERFORMED AND DID NOT IDENTIFY A TREND VIOLATION. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE ALINITY M HSV 1 & 2 / VZV AMP KIT (LIST 09N61-090) LOT 409807 WAS NOT IDENTIFIED.