Elecsys proBNP II STAT Immunoassay 09315276160Recalls & reported problems
Roche Diagnostics GmbH · proBNP G2 STAT Elecsys cobas e 100 V2.1 · Class 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 07613336191576), received between Aug 30, 2023 and Nov 6, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Low Test Results2
- High Test Results1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Non Reproducible Results1
- Output 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 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 36 PG/ML WITH A DATA FLAG. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 4534 PG/ML AND WAS BELIEVED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620526 ↗MalfunctionAug 30, 2023High Test Results; Low Test Results; High Test Results; Low Test Results
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS PROBNP II STAT IMMUNOASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS REPORTED TO THE MEDICAL PERSONNEL WHO REQUESTED A RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2023, THE INITIAL RESULT WAS 36.00 PG/ML WITH A DATA FLAG. ON 04-AUG-2023, THE REPEAT RESULT WAS 16932 PG/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17654855 ↗
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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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