PHADIA 1000

Additional Manufacturer Narrative

DISCREPANCIES WERE FOUND WITH A PATIENT'S RESULTS FOR MULTIPLE IMMUNOCAP ALLEGEN(S)/ ALLERGEN COMPONENT(S). THE SAMPLE WAS INITIALLY TESTED ((B)(6) 2025) ON PHADIA 1000 INSTRUMENT, SERIAL NUMBER: (B)(6), YIELDING THE FOLLOWING RESULTS: IMMUNOCAP ALLERGEN F13, PEANUT: <0.10/ CLASS 0. IMMUNOCAP ALLERGEN COMPONENT RARA H2 PEANUT F423: 0.09/ CLASS 0. IMMUNOCAP ALLERGEN F23, CRAB: <0.10/ CLASS 0. IMMUNOCAP ALLERGEN F202 CASHEW NUT: <0.10/ CLASS 0. IMMUNOCAP ALLERGEN F207, CLAM: <0.10/ CLASS 0. IMMUNOCAP ALLERGEN F290, OYSTER: <0.10/ CLASS 0. IMMUNOCAP ALLERGEN F338, SCALLOP: <0.10/ CLASS 0. THE SAMPLE WAS REPEATED (10/01/2025) ON ALTERNATE PHADIA 1000 INSTRUMENT, SERIAL NO: (B)(6), THE SAME IMMUNOCAP ALLEGEN(S)/ ALLERGEN COMPONENT(S) YIELDED THE FOLLOWING RESULTS: IMMUNOCAP ALLERGEN F13, PEANUT: >100/ CLASS 6. IMMUNOCAP ALLERGEN COMPONENT RARA H2 PEANUT F423: >100/ CLASS 6. IMMUNOCAP ALLERGEN F23, CRAB: 33.2/ CLASS 4. IMMUNOCAP ALLERGEN F202, CASHEW NUT: 21.1/ CLASS 4. IMMUNOCAP ALLERGEN F207, CLAM: 13.6/ CLASS 3. IMMUNOCAP ALLERGEN F290, OYSTER: 7.60/ CLASS 3. IMMUNOCAP ALLERGEN F338, SCALLOP: 20.9/ CLASS 4. THE REPEAT TEST RESULTS ALIGNED MORE WITH THE PATIENT'S HISTORY. INVESTIGATION IS ONGOING TO DETERMINE POSSIBLE ROOT-CAUSE. THERE IS INSUFFICIENT INFORMATION IF ANY ADVERSE EVENT HAS OCCURED.

Description of Event or Problem

DISCREPANCIES WERE FOUND WITH A PATIENT'S RESULTS FOR MULTIPLE IMMUNOCAP ALLERGEN(S) / ALLERGEN COMPONENT(S). THE PATIENT SAMPLE WAS TESTED ON PHADIA 1000 INSTRUMENT (SERIAL NUMBER: (B)(6)) WITH IMMUNOCAP ALLERGEN(S) / ALLERGEN COMPONENT(S) YIELDING NEGATIVE RESULTS. THE SAMPLE WAS TESTED AGAIN ON ALTERNATE PHADIA 1000 INSTRUMENT (SERIAL NO: (B)(6)) WITH THE SAME IMMUNOCAP ALLERGEN(S) / ALLERGEN COMPONENT(S) AND YIELDED THE POSITIVE RESULTS. THE REPEAT TEST RESULTS ALIGNED MORE WITH THE PATIENT'S HISTORY.