ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, AND 510K/PMA/BLA OF K220949.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I CMV IGG RESULTS COMPARED TO ROCHE TECHNIQUE. SID (B)(6), (FEMALE) ON (B)(6) 2025, GENERATED ALINITY I CMV IGG REACTIVE OF 21.7 AU/ML. ADDITIONAL TESTING OF ALINITY I CMV IGM OF 1.25 INDEX, LOW POSITIVE. NO AVIDITY TESTING WAS PERFORMED. THE PATIENT WAS NOT PREGNANT ON THIS DATE. THE SAME PATIENT, USING ID (B)(6), ON (B)(6) 2026, GENERATED ALINITY I CMV IGG REACTIVE OF 24.1 AU/ML. ADDITIONAL TESTING OF ALINITY I CMV IGM OF 1.27 INDEX, LOW POSITIVE. THE SAMPLE WAS SENT TO ANOTHER LAB FOR AVIDITY TESTING, BECAUSE PATIENT WAS PREGNANT. ROCHE RESULT OF NO CMV IGG, SO AVIDITY COULD NOT BE RUN. THE CUSTOMER RETRIEVED THE SERUM SAMPLE FROM (B)(6) 2025 AND SENT TO ANOTHER LAB FOR AVIDITY TESTING. THE RESULT WAS NO CMV IGG. THE PATIENT IS KNOWN TO HAVE WEAKLY POSITIVE ANTI-CARDIOLIPIN IGM. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.