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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products NTpro BNP Reagent Pack

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  Class 2 Device Recall VITROS Immunodiagnostic Products NTpro BNP Reagent Pack see related information
Date Initiated by Firm March 07, 2017
Create Date April 08, 2017
Recall Status1 Terminated 3 on June 14, 2019
Recall Number Z-1765-2017
Recall Event ID 76665
510(K)Number K060632  
Product Classification Test,natriuretic peptide - Product Code NBC
Product VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Code Information Lot 1570 (expiry 22 March 2017),  Lot 1580 (expiry 13 April 2017),  Lot 1590 (expiry 27 April 2017)
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 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-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 3/7/2017, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-048) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers and distributors who were shipped VITROS NT-proBNP Reagent Packs, Lots 1570, 1580 and/or 1590 to inform them of the issue and provided further instructions.
Quantity in Commerce US: 6324; Foreign: 1868
Distribution Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBC and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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