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Access NT-proBNP
Beckman Coulter, Inc. · Model C71977 · UDI-DI 15099590760823
NBC
Prescription
10
510(k) clearances
467
Adverse events (3 deaths)
22
Recalls
37
Facilities
Description
The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated DxI Access Immunoassay Analyzers to aid in the following: 1. diagnosis of patients suspected of having acute heart failure in the Emergency Department 2. assessment of heart failure severity 3. risk stratification of patients with heart failure 4. risk stratification of patients with acute coronary syndrome
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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Get your free API keyRead the docsData 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.