ALINITY I PROLACTIN REAGENT KIT
Received Mar 9, 2026 · Event occurred Sep 4, 2025
Report 3005094123-2026-00112 · MDR key 24547898
Device
Generic name
Radioimmunoassay, Prolactin (lactogen)
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P66-20
Lot number
77504UD00
Product problems
- High Test Results
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A 62-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6): INITIAL RESULT (LOT 72165UD00, (B)(6) = 1980.092 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3083.830 NG/ML, REPEAT WITH NO DILUTION (B)(6) = 3230.905 NG/ML. (B)(6) 2025, SID (B)(6): INITIAL RESULT (LOT 75050UD00, (B)(6) = 2225.910 NG/ML, REPEAT (B)(6) = 3468.409 NG/ML, REPEAT WITH 1:10 DILUTION (B)(6) = 3229.661 NG/ML. (B)(6) 2026, SID (B)(6): INITIAL RESULT = 3092.7 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ADDITIONAL INFORMATION FOR SECTION H10 RELATED REPORT NUMBERS: 3005094123-2026-00113.