ARCHITECT PROLACTIN
Received Mar 16, 2026 · Event occurred Feb 21, 2026
Report 3005094123-2026-00128 · MDR key 24606541
Device
Generic name
Radioimmunoassay, Prolactin (lactogen)
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K76-25
Lot number
80241UD00
Product problems
- High Test Results
Patient
27 YR · Female
- 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT PROLACTIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR A 27YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 ,SID (B)(6), INITIAL= >200 NG/ML /DILUTION=233.89 NG/ML. REPEATED ON ANOTHER ANALYZER MAGLUMI X3=18.9 NG/ML (REFERENCE RANGE=2.8 TO 29.2 NG/ML) THE SAMPLE WAS SENT TO ANOTHER LABORATORY; ELECTROCHEMILUMINESCENCE METHODOLOGY=26.4 NG/ML (REFERENCE RANGE=6.0 TO 29.9 NG/ML) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.