ALINITY I PROLACTIN REAGENT KIT
Received May 22, 2026 · Event occurred May 14, 2026
Report 3005094123-2026-00244 · MDR key 25256099
Device
Generic name
Radioimmunoassay, Prolactin (lactogen)
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P66-20
Lot number
85609UD00
Product problems
- High Test Results
Patient
52 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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 A FALSELY ELEVATED ALINITY I PROLACTIN FOR A 52-YEAR-OLD FEMALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 108.8 TO 557.1 MIU/L): (B)(6) 2026, SID (B)(6), INITIAL PROLACTIN RESULT (LOT 84437UD00, ANALYZER (B)(6)= 1398.20 MIU/L; REPEAT RESULT= 1,379.36 MIU/L; (B)(6) 2026, SID (B)(6), PROLACTIN RESULT (LOT 85609UD00, ANALYZER (B)(6)= 1,225.33 MIU/L; REPEAT USING BECKMAN PLATFORM= 298 MIU/L (REFERENCE RANGE 83 TO 504 MIU/L); REPEAT USING ROCHE PLATFORM= 492 MIU/L (REFERENCE RANGE 102 TO 496 MIU/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.