IMMULITE® 2000 Systems AF AFP 10381187Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · AF AFP Kit 200 Test · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414961033), received between Nov 15, 2019 and Sep 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Low Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777627 ↗MalfunctionNov 19, 2021Low Test Results; Low Test Results
THE CUSTOMER REPORTED A DISCORDANT DEPRESSED ALPHA FETOPROTEIN (AFP) RESULT FOR A FEMALE PATIENT'S SAMPLE WITH THE IMMULITE 2000 XPI AFP. THE PATIENT SAMPLE WAS DILUTED AND THE DILUTED RESULT WAS HIGHER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, IMMULITE 2000 XPI AFP RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12844271 ↗MalfunctionNov 15, 2019Low Test Results; Low Test Results
TWO DISCORDANT, FALSELY DEPRESSED ALPHA-FETOPROTEIN (AFP) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). A REPEAT RESULT WAS OBTAINED ON IMMULITE 2000 XPI AND WAS CONSIDERED DISCORDANT. ADDITIONAL REPEATED RESULTS WERE OBTAINED USING SIEMENS' ADVIA CENTAUR XP. THE REPEAT RESULTS FROM ADVIA CENTAUR XP WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED AFP RESULTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9329763 ↗
Other Kit, Test, Alpha-Fetoprotein For Neural Tube Defects devices
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- ADVIA Centaur® AFP 10309980Siemens Healthcare Diagnostics Inc. · Kit, Test, Alpha-Fetoprotein For Neural Tube Defects19 reports
- ARCHITECT 3P36-35Abbott Ireland Diagnostics · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS10 reports
- Alinity 07P9030Abbott Ireland Diagnostics · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS5 reports
- Alinity 07P9020Abbott Ireland Diagnostics · KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS3 reports
- Access AFP 33211Beckman Coulter, Inc. · Kit, Test, Alpha-Fetoprotein For Neural Tube Defects1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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