ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: 08MAY2023 SID (B)(6) INITIAL RESULT = 9.4 AU/ML (REACTIVE), REPEAT = NONREACTIVE. ADDITIONAL LABORATORY DATA WAS PROVIDED: CMV IGM RESULT = 0.09 INDEX. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR REACTIVE ALINITY I CMV IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 45608FN00 AND COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT 45608FN00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CMV IGG REAGENT FOR LOT 45608FN00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023, SID (B)(6), INITIAL RESULT = 9.4 AU/ML (REACTIVE), REPEAT = NONREACTIVE ADDITIONAL LABORATORY DATA WAS PROVIDED: CMV IGM RESULT = 0.09 INDEX. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33.