ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE FEMALE PATIENT WHO IS PREGNANT AND CLOSE TO DELIVERY. SID (B)(6) INITIAL RESULT = 30.9 AU/ML (REACTIVE). HISTORICAL RESULTS WERE ALWAYS NON-REACTIVE. CMV IGM RESULT = 0.53 INDEX (NONREACTIVE). THE SAMPLE WAS REPEATED THE FOLLOWING DAY AND GENERATED A CMV IGG RESULTS OF 30.6 AU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.