Elecsys hGH 5390125190Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630926664), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (1 report).
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
- Non Reproducible Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2019Non Reproducible Results; Non Reproducible Results
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. NON-REPRODUCIBLE RESULTS WERE GENERATED BY THE COBAS 6000 E 601 MODULE OR THE COBAS 8000 E 602 MODULE. THE EVENT INVOLVED A TOTAL OF 2 PATIENTS TESTED FOR ELECSYS HGH. THE PATIENTS' AGES RANGED FROM 56 - 64 YEARS. THERE WAS 1 MALE AND 1 FEMALE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8549729 ↗
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
- IMMULITE 2000 Systems Growth Hormone 10381451Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE2 reports
- 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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