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Access BNP II

Beckman Coulter, Inc. · Model D06227 · UDI-DI 15099590786533

NBC Prescription

510(k) clearances

467

Adverse events (3 deaths)

Recalls

Facilities

Description

The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: • as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure • for the risk stratification of patients with acute coronary syndromes • for the risk stratification of patients with heart failure

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 concentrations which are
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, higher measurement
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-Diluent 15 and certain l
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 these affected NT-p
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 human-readable side
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.