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.
FDA Recall Z-0689-2019 · Posted None
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Recalling FirmORTHO-CLINICAL DIAGNOSTICS
Recall StatusOpen, Classified
Product CodeNBC
Date Initiated2018-11-01
Product Quantity46598 total, 46062 units in US (100 tests per unit)
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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