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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS NTproBNP Reagent

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  Class 2 Device Recall VITROS NTproBNP Reagent see related information
Date Initiated by Firm November 01, 2018
Create Date January 03, 2019
Recall Status1 Open3, Classified
Recall Number Z-0689-2019
Recall Event ID 81682
510(K)Number K060632  
Product Classification Test, natriuretic peptide - Product Code NBC
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, 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.
Code Information All expired, in-date, and future lots released.
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
Felindre Meadows
Bridgend United Kingdom
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action On November 1, 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 46598 total, 46062 units in US (100 tests per unit)
Distribution Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NBC and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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