ALINITY I HSV-2 IGG

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04W21-25 AND THERE IS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER SIMILAR US LN 04W21-27/37. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED, FALSE NONREACTIVE HSV-1 IGG AND HSV-2 IGG RESULTS. GENERATED BY THE ALINITY I PROCESS MODULE FOR A PATIENT WHO TESTED POSITIVE ON THE VIRCLIA METHOD. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): SID# (B)(6): HSV-1 IGG RESULT (ALINITY) = 0.1 S/CO (NONREACTIVE) HSV-2 IGG RESULT (ALINITY) = 0.16 S/CO (NONREACTIVE) VIRCLIA RESULT = 4.354 S/CO (POSITIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.