IMMULITE 2000 AFP
Received Jun 24, 2026 · Event occurred May 13, 2026
Report 1219913-2026-00127 · MDR key 25607647
Device
Generic name
Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedCatalog number
10381187
Lot number
539
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN OUTSIDE OF UNITED STATES (OUS) CUSTOMER REPORTED THE OBSERVATION OF A DISCORDANT, DEPRESSED IMMULITE 2000 ALPHA-FETOPROTEIN (AFP) PATIENT RESULT WHEN COMPARED TO ATELLICA IM AFP AND AN ALTERNATE METHOD. ON IMMULITE 2000 NORMAL RESULT < 5.5 IU/ML IS OBSERVED, WHILE IN ATELLICA IM AFP AND THE ALTERNATE METHOD THE RESULTS ARE PATHOLOGICAL WITH THEIR OWN REFERENCE RANGES. QUALITY CONTROL WAS WITHIN RANGE AT TIME OF TESTING. SIEMENS IS INVESTIGATING.
Description of Event or Problem
THE CUSTOMER REPORTED THE OBSERVATION OF A DISCORDANT, DEPRESSED IMMULITE 2000 ALPHA-FETOPROTEIN (AFP) PATIENT RESULT USING AFP KIT LOT: 539 WHEN COMPARED TO ATELLICA IM AFP AND AN ALTERNATE METHOD. ON IMMULITE 2000 NORMAL RESULT < 5.5 IU/ML IS OBSERVED, WHILE IN ATELLICA AND THE ALTERNATE METHOD THE RESULTS ARE PATHOLOGICAL WITH THEIR OWN REFERENCE RANGES. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.