Elecsys HCG+ beta 09744428190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
All models of Elecsys HCG+ beta (2)
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 07613336217535), received between Aug 1, 2025 and Nov 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Non Reproducible 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.
Reports received per month
Most reported problems
Device problems
- Non Reproducible Results2
- High Test Results1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Mechanical Problem1
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.
MalfunctionNov 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+ BETA RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 238 MIU/ML. ON (B)(6) 2025, A NEW SAMPLE WAS COLLECTED WITH THE RESULT OF < 1 MIU/ML. THE INITIAL SAMPLE WAS REPEATED, AND THE RESULT WAS < 1 MIU/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23636036 ↗MalfunctionAug 1, 2025Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 5 PATIENT SAMPLES TESTED FOR ELECSYS HCG+SS (HCG + B) ON TWO COBAS E 801 ANALYTICAL UNITS. (ANALYZER 1 AND ANALYZER 2) DISCREPANT RESULTS FOR 3 PATIENT SAMPLES WERE PROVIDED. PATIENT 1 INITIAL RESULT FROM ANALYZER 2 WAS 0.2 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 34.5 MIU/ML. PATIENT 2 INITIAL RESULT FROM ANALYZER 2 WAS 0.200 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 41.7 MIU/ML. ON (B)(6) 2025, PATIENT 3 INITIAL RESULT FROM ANALYZER 1 WAS 0.2 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 72.7 MIU/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686375 ↗
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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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