ALINITY S CHAGAS REAGENT KIT
Received Jun 23, 2026 · Event occurred Apr 5, 2026
Report 1415939-2026-00016 · MDR key 25601952
Device
Generic name
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donatio
Manufacturer
Abbott LaboratoriesCatalog number
06P08-61
Lot number
75047MM00
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S CHAGAS AND PROVIDED THE FOLLOWING DATA: SAMPLE ID: (B)(6) ¿ FEMALE, 19 ON (B)(6), 2026, THE RESULTS WERE 1.02 S/CO, 1.02 S/CO, AND 1.06 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS NEGATIVE. SAMPLE ID: (B)(6) ¿ MALE, 17 ON (B)(6) 2026, THE RESULTS WERE 2.88 S/CO, 2.86 S/CO, AND 2.86 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS INDETERMINATE. SAMPLE ID: (B)(6) ¿ MALE, 35 ON (B)(6), 2026, THE RESULTS WERE 1.22 S/CO, 1.18 S/CO, AND 1.17 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS NEGATIVE. SAMPLE ID: (B)(6)¿ MALE, 19 ON (B)(6), 2026, THE RESULTS WERE 1.73 S/CO, 1.76 S/CO, AND 1.68 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS INDETERMINATE. SAMPLE ID: (B)(6)¿ MALE, 39 ON (B)(6), 2026, THE RESULTS WERE 1.87 S/CO, 1.85 S/CO, AND 1.85 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS INDETERMINATE. SAMPLE ID: (B)(6) ¿ MALE, 19 ON (B)(6), 2026, THE RESULTS WERE 2.16 S/CO, 2.19 S/CO, AND 2.10 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS INDETERMINATE. SAMPLE ID: (B)(6)¿ MALE, 56 ON (B)(6), 2026, THE RESULTS WERE 1.27 S/CO, 1.30 S/CO, AND 1.30 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS NEGATIVE. SAMPLE ID: (B)(6)¿ MALE, 17 ON (B)(6), 2026, THE RESULTS WERE 1.55 S/CO, 1.53 S/CO, AND 1.48 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS INDETERMINATE. SAMPLE ID: (B)(6) ¿ FEMALE, 38 ON (B)(6), 2026, THE RESULTS WERE 1.01 S/CO AND 1.04 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS INDETERMINATE. SAMPLE ID: (B)(6). ON (B)(6), 2026, THE RESULTS WERE 9.77 S/CO, 10.19 S/CO, AND 9.27 S/CO WITH LOT 75047MM00 ON ANALYZER (B)(6); CONFIRMATORY TESTING WAS NOT AVAILABLE. THE CONFIRMATORY TEST UTILIZED FOR CHAGAS WAS CESA. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.