ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS ON A PATIENT DIAGNOSED WITH PANCREATIC CANCER THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 1042.69 / >1200 U/ML/ MANUAL X3 DILUTION = 682.67 U/ML / 1066.4 U/ML / AUTO-DILUTION = 521.08 U/ML. ECLIA PLATFORM = 435 U/ML (CUTOFF = <34 U/ML). ADDITIONALLY PERFORMED SERIAL DILUTION FOR ABOVE MENTIONED SAMPLE ON (B)(6) 2025: NEAT- 696 U/ML, 1:2 -878.79 U/ ML, 1:4 - 781.23 U/ML, 1:8 - 823.35 U/ML, 1:16 - 739.83 U/ML, 1:32- <960 U/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 75647FP00. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. HISTORICAL PERFORMANCE OF REAGENT LOT 75647FP00 WAS REVIEWED USING WORLDWIDE DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 75647FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 75647FP00. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED AND THE PRODUCT IS PERFORMING AS EXPECTED.

Additional Manufacturer Narrative

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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21, WITH 510K/PMA/BLA NUMBER K052000.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS ON A PATIENT DIAGNOSED WITH PANCREATIC CANCER THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6) = 1042.69 / >1200 U/ML/ MANUAL X3 DILUTION = 682.67 U/ML / 1066.4 U/ML / AUTO-DILUTION = 521.08 U/ML. ECLIA PLATFORM = 435 U/ML (CUTOFF = <34 U/ML) ADDITIONALLY PERFORMED SERIAL DILUTION FOR ABOVE MENTIONED SAMPLE ON (B)(6) 2025: NEAT- 696 U/ML, 1:2 -878.79 U/ ML, 1:4 - 781.23 U/ML, 1:8 - 823.35 U/ML, 1:16 - 739.83 U/ML, 1:32- <960 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.