IMMULITE 2000 Systems Growth Hormone 10381451Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · hGH - IMMULITE - RGT - 200 Tests · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414961552), received between Jul 19, 2023 and Jul 19, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (2 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.
Most reported problems
Device problems
- Low Test Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2023Low Test Results; Low Test Results
THE CUSTOMER OBTAINED DISCORDANT LOW RESULTS FOR ONE PATIENT WITH IMMULITE 2000 XPI GROWTH HORMONE (HGH), LOT 235. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED ON A DIFFERENT DAY AND THE RESULT WAS LOW. THE SAMPLE WAS SENT TO ANOTHER LABORATORY, TESTED WITH AN ALTERNATE METHOD AND A RESULT OF 53.3 NG/ML WAS OBTAINED. THIS HIGHER RESULT WAS IN LINE WITH PHYSICIAN´S EXPECTATIONS. A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HGC RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17353971 ↗MalfunctionJul 19, 2023Low Test Results; Low Test Results
THE CUSTOMER OBTAINED DISCORDANT LOW RESULTS FOR ONE PATIENT WITH IMMULITE 2000 XPI GROWTH HORMONE (HGH), LOT 235. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED ON A DIFFERENT DAY AND THE RESULT WAS LOW. THE SAMPLE WAS SENT TO ANOTHER LABORATORY, TESTED WITH AN ALTERNATE METHOD AND A RESULT OF 53.3 NG/ML WAS OBTAINED. THIS HIGHER RESULT WAS IN LINE WITH PHYSICIAN´S EXPECTATIONS. A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HGC RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17353940 ↗
Other RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE devices
- IMMULITE® 2000 Systems IGF-I 11128543Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE21 reports
- Elecsys IGF-1 07475896190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE7 reports
- Elecsys IGF-1 07475918190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE5 reports
- IMMULITE® 2000 Systems IGFBP-3 10381447Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE3 reports
- Elecsys IGFBP-3 07574690190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE2 reports
- Elecsys hGH 5390125190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE1 report
- IMMULITE® 2000 Systems IGF-1 10381448Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE1 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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