Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results
Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where biased diagnostic results could lead to incorrect clinical decisions, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics is extending its previous July 2018 recall to include additional product codes for the VITROS NT-proBNP Reagent (Cat No. 6802156). This in vitro diagnostic reagent is used to measure N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma to aid in the diagnosis of congestive heart failure and risk stratification of acute coronary syndrome.
The recall is being issued because biased results may occur for these additional products at biotin concentrations that are lower than indicated in the current Instructions for Use. The recall includes all expired, in-date, and future lots released.
The affected product was distributed worldwide, including nationwide in the United States and in various international markets. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- 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…
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All expired
- in-date
- and future lots released.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by ORTHO-CLINICAL DIAGNOSTICS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · ORTHO-CLINICAL DIAGNOSTICS
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateOrtho VITROS Prolactin Reagent Pack Recalled for Biotin Interference
FDA (Devices) · 2018-10-10
- ModerateOrtho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent Packs Due to Calibration Failures
FDA (Devices) · 2017-04-19
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Intact PTH Reagent Packs
FDA (Devices) · 2017-01-04
- HighOrtho-Clinical Diagnostics Recalls VITROS VALP Reagent Packs Due to Negative Bias
FDA (Devices) · 2019-02-27
- ModerateOrtho VITROS TSH Reagent Packs Recalled for Potential Biotin Interference
FDA (Devices) · 2018-10-10
- ModerateOrtho VITROS FSH Reagent Pack Recalled for Potential Biased Results
FDA (Devices) · 2018-10-10