Elecsys ProBNP II 09744959190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
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 07613336217689), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PROBNP II RESULTS FROM FOUR SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 402 ANALYTICAL UNIT. ON (B)(6) 2025, THE RESULT FROM THE ANALYZER WAS <5.00 PG/ML WITH A DATA FLAG. THE REPORTER STATED THAT THE RESULTS WERE DISCREPANT WITH THE PATIENT'S CLINICAL FINDINGS. ON (B)(6) 2025, THE INVESTIGATION LABORATORY RERAN THE PATIENT'S SAMPLES. THE RESULT OF THE PATIENT'S SAMPLE COLLECTED ON (B)(6) 2025 WAS <5.00 PG/ML WITH A DATA FLAG. THE RESULT OF THE PATIENT'S SAMPLE COLLECTED ON (B)(6) 2025 WAS <5.00 PG/ML WITH A DATA FLAG. THE RESULT OF THE PATIENT'S SAMPLE COLLECTED ON (B)(6) 2025 WAS <5.00 PG/ML WITH A DATA FLAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22714435 ↗
Other Test, natriuretic peptide devices
- PATHFAST NTproBNP N/APhc Corporation · Test,Natriuretic Peptide1 recall0 reports
- VITROS 6192255Ortho Clinical Diagnostics · Test, natriuretic peptide18 reports
- Elecsys proBNP II Immunoassay 09315284190Roche Diagnostics GmbH · Test, natriuretic peptide8 reports
- Elecsys proBNP II Immunoassay 09315268160Roche Diagnostics GmbH · Test, natriuretic peptide5 reports
- VITROS 6802156Ortho Clinical Diagnostics · TEST,NATRIURETIC PEPTIDE3 reports
- Elecsys proBNP II STAT Immunoassay 09315276160Roche Diagnostics GmbH · Test, natriuretic peptide2 reports
- i-STAT 03P93-25Abbott Point Of Care Inc. · TEST,NATRIURETIC PEPTIDE2 reports
- Access BNP 98200Beckman Coulter, Inc. · Test, Natriuretic Peptide2 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page