Class 3 Device Recall VIDAS NT PRO BNP 2

• Date Initiated by Firm: April 15, 2016
• Date Posted: September 10, 2016
• Recall Status: Terminated on July 21, 2017
• Recall Number: Z-2779-2016
• Recall Event ID: 73989
• 510(K)Number: K073091
• Product Classification: Test,natriuretic peptide - Product Code NBC
• Product: VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
• Code Information: Reference number: 30449-01, Lot #1004474560.
• FEI Number: 1000611339
• Recalling Firm/ Manufacturer: Biomerieux France Chemin De L'Or; Chemin De L'Orme; Marcy L'Etoile France
• For Additional Information Contact: Ryan LeMelle; 314-731-8582
• Manufacturer Reason for Recall: Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
• FDA Determined Cause: Packaging
• Action: bioMerieux. sent an Urgent Product Removal Notice letter dated April 26, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check for affected products in their inventory and discard the incomplete products. Customers were asked to complete the attached Acknowledgement Form and return it via fax to bioMerieux. For questions contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666.
• Quantity in Commerce: 229 kits
• Distribution: US Nationwide Distribution in the states of: AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.
• 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