Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall VIDAS NT PRO BNP 2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall VIDAS NT PRO BNP 2 see related information
Date Initiated by Firm April 15, 2016
Date Posted September 10, 2016
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = BIOMERIEUX, INC.
-
-