Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS NT-proBNP Reagent Recalled by ORTHO-CLINICAL DIAGNOSTICS Due to The firm is extending their previous July 2018...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ORTHO-CLINICAL DIAGNOSTICS directly.
Affected Products
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
Quantity: 46598 total, 46062 units in US (100 tests per unit)
Why Was This Recalled?
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 lower than indicated in the current Instructions for Use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ORTHO-CLINICAL DIAGNOSTICS
ORTHO-CLINICAL DIAGNOSTICS has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report