ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR THREE PATIENTS THAT WERE NONREACTIVE WHEN RETESTED. THE FOLLOWING RESULTS WERE PROVIDED (<6.0 AU/ML IS NONREACTIVE, >/= TO 6.0 AU/ML IS REACTIVE): SID (B)(6), (B)(6) 2025, INITIAL ALINITY I CMV IGG RESULT 7.1 AU/ML, RETESTED 1.9 AU/ML. SID (B)(6), (B)(6) 2025, INITIAL ALINITY I CMV IGG RESULT 6.2 AU/ML, RETESTED (B)(6) 2025 RESULT 0.6 AND 0.6 AU/ML. SID (B)(6), (B)(6) 2025, INITIAL ALINITY I CMV IGG RESULT 36.5 AU/ML, RETESTED (B)(6) 2025 RESULT 0.1 AND 0.1 AU/ML. 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 07P42-22THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K NUMBER K220949.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I CMV IGG REAGENT, LOT 72312FZ00. 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. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF ALINITY I CMV IGG REAGENT LOT 72312FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE ALINITY I CMV IGG REAGENT, LOT 72312FZ00. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE ALINITY I CMV IGG ASSAY MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. FURTHER REVIEW OF THE INCIDENT IDENTIFIED THE ALINITY I PROCESSING MODULE LIST 03R65-01, SN (B)(6), AS A POTENTIAL CAUSE AS THE FIELD SERVICE REPRESENTATIVE CONDUCTED SYSTEM CHECKS AND REPLACED VARIOUS FLUIDICS COMPONENTS OF THE INSTRUMENT TO TROUBLESHOOT THE ISSUE. REFER TO MDR NUMBER 3016438761-2025-00602 FOR THE EVALUATION OF THE ALINITY I PROCESSING MODULE LIST 03R65-01, SN (B)(6).

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR THREE PATIENTS THAT WERE NONREACTIVE WHEN RETESTED. THE FOLLOWING RESULTS WERE PROVIDED (<6.0 AU/ML IS NONREACTIVE, >/= TO 6.0 AU/ML IS REACTIVE): SID (B)(6), (B)(6) 2025 INITIAL ALINITY I CMV IGG RESULT 7.1 AU/ML, RETESTED 1.9 AU/ML. SID (B)(6), (B)(6) 2025 INITIAL ALINITY I CMV IGG RESULT 6.2 AU/ML, RETESTED (B)(6) 2025 RESULT 0.6 AND 0.6 AU/ML. SID (B)(6), (B)(6) 2025 INITIAL ALINITY I CMV IGG RESULT 36.5 AU/ML, RETESTED (B)(6) 2025 RESULT 0.1 AND 0.1 AU/ML. UPDATE: ON 26AUG2025, RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE SAMPLES AND RESULTS: COLLECTION TIMING SAMPLE 1 (SERUM) NOT HEMOLYZED, NO VISIBLE PARTICLES.: REGISTERED IN THE LAB: (B)(6) 2025 AT 10:39 CENTRIFUGED: (B)(6) 2025 AT 11:09 SENT TO ALINITY VIA TRACK: (B)(6) 2025 AT 11:57 CENTRIFUGATION PROTOCOL: RCF 1999G FOR 8 MINUTES AT 22°C TIME OF COLLECTION IN CLINIC: UNKNOWN. SAMPLE 2 (SERUM) NOT HEMOLYZED, NO VISIBLE PARTICLES: REGISTERED IN THE LAB: (B)(6) 2025 AT 12:09 CENTRIFUGED: (B)(6) 2025 AT 12:13 SENT TO ALINITY VIA TRACK: (B)(6) 2025 AT 12:37 CENTRIFUGATION PROTOCOL: RCF 2000G FOR 8 MINUTES AT 22°C TIME OF COLLECTION IN CLINIC: UNKNOWN. RE-CENTRIFUGATION BEFORE REPEAT TESTING SAMPLES WERE NOT RE-CENTRIFUGED. POST-ANALYTICAL ALIQUOTS WERE USED FOR REPEAT TESTING. FOLLOW-UP TESTING FOR BORDERLINE RESULTS (6¿15 AU/ML) SAMPLE 1: CMV IGM ALSO TESTED ON (B)(6) 2025: 0.05 AU/ML (NEGATIVE) NO REPEAT CMV IGG TEST WITH A FRESH SAMPLE WITHIN 2 WEEKS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR THREE PATIENTS THAT WERE NONREACTIVE WHEN RETESTED. THE FOLLOWING RESULTS WERE PROVIDED (<6.0 AU/ML IS NONREACTIVE, >/= TO 6.0 AU/ML IS REACTIVE): SID (B)(6), ON (B)(6) 2025 INITIAL ALINITY I CMV IGG RESULT 7.1 AU/ML, RETESTED 1.9 AU/ML. SID (B)(6) ON (B)(6) 2025 INITIAL ALINITY I CMV IGG RESULT 6.2 AU/ML, RETESTED ON (B)(6) 2025 RESULT 0.6 AND 0.6 AU/ML. SID (B)(6) ON (B)(6) 2025 INITIAL ALINITY I CMV IGG RESULT 36.5 AU/ML, RETESTED ON (B)(6) 2025 RESULT 0.1 AND 0.1 AU/ML. UPDATE: ON (B)(6) 2025, RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE SAMPLES AND RESULTS: COLLECTION TIMING. SAMPLE 1 (SERUM) NOT HEMOLYZED, NO VISIBLE PARTICLES.: REGISTERED IN THE LAB: (B)(6) 2025 AT 10:39. CENTRIFUGED: (B)(6) 2025 AT 11:09. SENT TO ALINITY VIA TRACK: 18JUL2025 AT 11:57. CENTRIFUGATION PROTOCOL: RCF 1999G FOR 8 MINUTES AT 22°C. TIME OF COLLECTION IN CLINIC: UNKNOWN. SAMPLE 2 (SERUM) NOT HEMOLYZED, NO VISIBLE PARTICLES: REGISTERED IN THE LAB: (B)(6) 2025 AT 12:09. CENTRIFUGED: (B)(6) 2025 AT 12:13. SENT TO ALINITY VIA TRACK: 30JUL2025 AT 12:37. CENTRIFUGATION PROTOCOL: RCF 2000G FOR 8 MINUTES AT 22°C. TIME OF COLLECTION IN CLINIC: UNKNOWN. RE-CENTRIFUGATION BEFORE REPEAT TESTING SAMPLES WERE NOT RE-CENTRIFUGED. POST-ANALYTICAL ALIQUOTS WERE USED FOR REPEAT TESTING. FOLLOW-UP TESTING FOR BORDERLINE RESULTS (6¿15 AU/ML). SAMPLE 1: CMV IGM ALSO TESTED ON (B)(6) 2025: 0.05 AU/ML (NEGATIVE). NO REPEAT CMV IGG TEST WITH A FRESH SAMPLE WITHIN 2 WEEKS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION FOUND IN SECTION B5 DESCRIBE EVENT OR PROBLEM AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.