IMMULITE® 2000 Systems AND Androstenedione 10381188Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · Androstenedione - IMMULITE - RGT - 200 Tests · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414961026), received between Feb 17, 2026 and Feb 20, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “High Test Results” (5 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
- High Test Results5
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Low Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF DEPRESSED DISCORDANT PATIENT RESULTS WITH ANDROSTENEDIONE (AND) REAGENT LOT 509 ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404965 ↗MalfunctionFeb 20, 2026High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF ELEVATED DISCORDANT PATIENT RESULTS WITH ANDROSTENEDIONE (AND) KIT LOT 509 ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404659 ↗MalfunctionFeb 19, 2026High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY ELEVATED ANDROSTENEDIONE RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). FOUR SAMPLES WERE RECTIFIED (SIDS (B)(6). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ANDROSTENEDIONE RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390173 ↗MalfunctionFeb 17, 2026High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ELEVATED ANDROSTENEDIONE PATIENT RESULTS WHEN USING KIT LOT 509 ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT AND THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363392 ↗MalfunctionFeb 17, 2026High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF A DISCORDANT ELEVATED ANDROSTENEDIONE PATIENT RESULT WHEN USING KIT LOT 509 ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULT WAS REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT AND THE REPEAT RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363319 ↗MalfunctionFeb 17, 2026High Test Results
THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ELEVATED ANDROSTENEDIONE PATIENT RESULTS WHEN USING KIT LOT 509 ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT AND THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363304 ↗
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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