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Alere NT-proBNP for Alinity Reagent Kit (200 Tests)

AXIS-SHIELD DIAGNOSTICS LIMITED · Model 04S7921 · UDI-DI 05055845400596

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510(k) clearances

467

Adverse events (3 deaths)

Recalls

Facilities

Description

The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system. In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.

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.