PATHFAST NTproBNP N/ARecalls & reported problems
Phc Corporation · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Apr 30, 2018Terminated
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.
Z-3186-2018 · Root cause: Process control · FDA record ↗
Other Test,Natriuretic Peptide devices
- 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
- i-STAT 03P93-25Abbott Point Of Care Inc. · TEST,NATRIURETIC PEPTIDE2 reports
- Access BNP 98200Beckman Coulter, Inc. · Test, Natriuretic Peptide2 reports
- Elecsys proBNP II STAT Immunoassay 09315276160Roche Diagnostics GmbH · Test, natriuretic peptide2 reports
- Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP 10464526Siemens Healthcare Diagnostics Inc. · TEST,NATRIURETIC PEPTIDE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.