Elecsys proBNP II 07027664190Recalls & 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 04015630939756), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test 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
- Low Test Results1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2018Low Test Results; Low Test Results
THE CUSTOMER RECEIVED QUESTIONABLE LOW ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR ONE PATIENT FROM A COBAS E 801 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. FOR MULTIPLE SAMPLES FROM THE PATIENT, THE ELECSYS PROBNP RESULT WAS ALWAYS <5 PG/ML, BUT THE BNP RESULTS WERE BETWEEN 20-49 PG/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN BELIEVED "THERE SHOULD BE HEART LOAD IN THE PATIENT" SINCE THE PATIENT HAS OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7722122 ↗
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.
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