ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I CMV IGG REAGENT LOT 72312FZ00 DID IDENTIFY AN INCREASE IN COMPLAINTS, HOWEVER, THE SEARCH BY LIST NUMBER DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE CURRENT COMPLAINT ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE SPECIFICITY TESTING WAS PERFORMED USING A RETAIN KIT OF ALINITY I CMV IGG REAGENT LOT 72312FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT LOT 72312FZ00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG FOR ONE PREGNANT PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <6 IU/ML): ON (B)(6) 2025, SID (B)(6), VIDAS TECHNIQUE RESULT= NEGATIVE. ON (B)(6) 2025, SID (B)(6); INITIAL CMV IGG RESULT= 20.4 IU/ML; FOR TROUBLESHOOTING PURPOSES ONLY, THE SAMPLE WAS SENT TO LIMOGES REFERENCE LAB AND PERFORMED ON AN ALINITY, RESULT= 18.4 IU/ML; DIASORIN METHOD RESULT= 25.6 IU/ML (REFERENCE RANGE <12 IU/ML). THE ARCHIVED TUBE FROM (B)(6) 2025 WAS TESTED ON THE ALINITY WITH RESULT= 23.5 IU/ML; FOR TROUBLESHOOTING PURPOSES ONLY, THE SAMPLE WAS SENT TO LIMOGES REFERENCE LAB AND PERFORMED ON THE ALINITY, RESULT= 24.2 IU/ML; DIASORIN METHOD RESULT= 27.2 IU/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K NUMBER K220949.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG FOR ONE PREGNANT PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE <6 IU/ML): ON (B)(6) 2025, SID (B)(6), VIDAS TECHNIQUE RESULT= NEGATIVE. ON (B)(6) 2025, SID (B)(6); INITIAL CMV IGG RESULT= 20.4 IU/ML; FOR TROUBLESHOOTING PURPOSES ONLY, THE SAMPLE WAS SENT TO (B)(6) LAB AND PERFORMED ON AN ALINITY, RESULT= 18.4 IU/ML; DIASORIN METHOD RESULT= 25.6 IU/ML (REFERENCE RANGE <12 IU/ML) THE ARCHIVED TUBE FROM (B)(6) 2025 WAS TESTED ON THE ALINITY WITH RESULT= 23.5 IU/ML; FOR TROUBLESHOOTING PURPOSES ONLY, THE SAMPLE WAS SENT TO (B)(6) LAB AND PERFORMED ON THE ALINITY, RESULT= 24.2 IU/ML; DIASORIN METHOD RESULT= 27.2 IU/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.