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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 Packsee related information
Date Initiated by FirmMarch 07, 2017
Create DateApril 08, 2017
Recall Status1 Terminated 3 on June 14, 2019
Recall NumberZ-1765-2017
Recall Event ID 76665
510(K)NumberK060632 
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 ContactMs. 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
ActionOn 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 CommerceUS: 6324; Foreign: 1868
DistributionWorldwide: 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 CycleTPLC 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) Database510(K)s with Product Code = NBC
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