ELECSYS CMV IGG

Additional Manufacturer Narrative

QUALITY CONTROLS RECOVERED WITHIN SPECIFIED RANGES. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

CMV IGG REAGENT LOT NUMBER 82318601 HAS AN EXPIRATION DATE OF 30-SEP-2025. THIS LOT WAS USED FOR TESTING OF THE FIRST PATIENT. CMV IGG REAGENT LOT NUMBER 79229801 HAS AN EXPIRATION DATE OF 31-MAY-2025. THIS LOT WAS USED FOR TESTING OF THE SECOND PATIENT. THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE NEGATIVE RESULTS FOR SAMPLES FROM TWO PATIENTS TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. A FIRST SAMPLE COLLECTED FROM THE FIRST PATIENT RESULTED IN A CMV IGG VALUE OF < 0.15 AU/ML (NEGATIVE) ON (B)(6) 2025. WHEN REPEATED USING THE VIDAS METHOD, THE RESULT WAS "AROUND 10 AU/ML" (POSITIVE). A SECOND SAMPLE COLLECTED FROM THE FIRST PATIENT RESULTED IN A CMV IGG VALUE OF < 0.15 AU/ML (NEGATIVE) ON (B)(6) 2026. WHEN REPEATED USING THE VIDAS METHOD, THE RESULT WAS "AROUND 10 AU/ML" (POSITIVE). A SAMPLE COLLECTED FROM THE SECOND PATIENT RESULTED IN A CMV IGG VALUE OF < 0.15 AU/ML (NEGATIVE) ON (B)(6) 2026. WHEN REPEATED USING THE VIDAS METHOD, THE RESULT WAS "AROUND 10 AU/ML" (POSITIVE).