IMMULITE® 2000 Systems UE3 Unconjugated Estriol 10381192Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · Estriol unconjugated - IMMULITE - RGT - 200 Tests · Class 1
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 00630414997162), received between Sep 7, 2022 and Nov 12, 2024 — 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 Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2024Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSELY DEPRESSED UNCONJUGATED ESTRIOL RESULTS FOR SEVEN PATIENT SAMPLES USING KIT LOT 515 ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI USING KIT LOTS 515 AND 518 AND THE TRUE RESULTS WERE STILL NOT KNOWN. THE SAMPLES WERE THEN TESTED USING A NON-SIEMENS INSTRUMENT AND THE RESULTS WERE HIGHER THAN THE IMMULITE 2000 XPI RESULTS. THE RESULTS OBTAINED USING THE NON-SIEMENS INSTRUMENT WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED UNCONJUGATED ESTRIOL RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663242 ↗MalfunctionNov 12, 2024Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSELY DEPRESSED UNCONJUGATED ESTRIOL RESULTS FOR SEVEN PATIENT SAMPLES USING KIT LOT 515 ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI USING KIT LOTS 515 AND 518 AND THE TRUE RESULTS WERE STILL NOT KNOWN. THE SAMPLES WERE THEN TESTED USING A NON-SIEMENS INSTRUMENT AND THE RESULTS WERE HIGHER THAN THE IMMULITE 2000 XPI RESULTS. THE RESULTS OBTAINED USING THE NON-SIEMENS INSTRUMENT WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED UNCONJUGATED ESTRIOL RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663240 ↗MalfunctionSep 7, 2022Low Test Results; Low Test Results
THE CUSTOMER RAN A PRENATAL SCREENING SAMPLE ON IMMULITE 2000 XPI UNCONJUGATED ESTRIOL (UE3), WHICH WAS OUT OF ADJUSTMENT. THIS LED TO A FALSELY DEPRESSED UE3 RESULT, INDICATING HIGH-RISK FOR TRISOMY 18. UPON RETEST, THE UE3 RESULT WAS HIGHER (LOW RISK FOR TRISOMY 18). IT IS CURRENTLY UNCLEAR WHETHER THE INITIAL FALSLEY DEPRESSED RESULT WAS REPORTIED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE UE3 RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15372957 ↗
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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