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Test, Natriuretic Peptide
FDA product code NBC · Class 2 · Clinical Chemistry
63
Registered devices
467
Adverse events
22
Recalls
45
510(k) clearances
Devices with this code
Nano-CheckTM 4 in 1 Test — NANO-DITECH CORPORATIONDimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge — Siemens Healthcare Diagnostics Inc.ADVIA Centaur PBNPII — Siemens Healthcare Diagnostics Inc.Alere Triage® — Alere San Diego, Inc.Elecsys ProBNP II — Roche Diagnostics GmbHTriage — QUIDEL CARDIOVASCULAR INC.VITROS — ORTHO CLINICAL DIAGNOSTICSTriage — QUIDEL CARDIOVASCULAR INC.Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge — Siemens Healthcare Diagnostics Inc.Atellica IM BNP — Siemens Healthcare Diagnostics Inc.ADVIA Centaur PBNPII — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESElecsys proBNP II STAT Immunoassay — Roche Diagnostics GmbHTriage — QUIDEL CARDIOVASCULAR INC.Atellica IM PBNPII — Siemens Healthcare Diagnostics Inc.Triage — QUIDEL CARDIOVASCULAR INC.Alere Triage® — Alere San Diego, Inc.ARCHITECT — Abbott GmbHARCHITECT — ABBOTT LABORATORIESADVIA Centaur® BNP — Siemens Healthcare Diagnostics Inc.Elecsys proBNP II — Roche Diagnostics GmbHAtellica IM BNP QC — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge PBNP — Siemens Healthcare Diagnostics Inc.Access BNP — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-01 | Medline Industries Inc | Product compromised during shipment. |
| 2018-11-01 | ORTHO-CLINICAL DIAGNOSTICS | The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin conc |
| 2018-04-30 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc | 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 |
| 2017-12-18 | Siemens Healthcare Diagnostics, Inc. | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Dilu |
| 2017-03-07 | ORTHO-CLINICAL DIAGNOSTICS | Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for |
| 2016-04-15 | Biomerieux France Chemin De L'Or | Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2014-10-06 | Siemens Healthcare Diagnostics, Inc | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 |
| 2014-06-23 | Siemens Healthcare Diagnostics, Inc | Complaints of failed calibration. |
| 2014-06-23 | Siemens Healthcare Diagnostics, Inc | Complaints of failed calibration. |
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