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U.S. Department of Health and Human Services

Class 3 Device Recall BD ReticCount" Reticulocyte Reagent System

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  Class 3 Device Recall BD ReticCount" Reticulocyte Reagent System see related information
Date Initiated by Firm March 18, 2016
Create Date April 14, 2016
Recall Status1 Terminated 3 on December 02, 2016
Recall Number Z-1390-2016
Recall Event ID 73597
510(K)Number K880636  
Product Classification Counter, cell, automated (particle counter) - Product Code GKL
Product BD-Retic-Count Reticulocyte Reagent System;

Hematology: Used for in vitro diagnostics
Code Information Product number 349214, Lot number 5175559, Expiry 5/31/16.
Recalling Firm/
Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Melissa J. Quinn
Manufacturer Reason
for Recall
The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.
FDA Determined
Cause 2
Under Investigation by firm
Action BD Biosciences sent an Urgent Product Recall letter on March 18, 2016, to all affected customers by certified mail. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Examine your data files obtained using reagents from the affected lots for low performance. 2. Discard all remaining stock of BD Retic-Counter reticulocyte reagent system, Catalog Number 349204, lot number 5175559, and request replacement product. BD will replace product at no cost. 3. As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking/Verification form , even if you no longer have the affected reagents listed in your inventory. Please return the Tracking/Verification form to BD Biosciences, per the instructions (mail, fax, or email). If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.
Quantity in Commerce 205
Distribution Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN., and to the countries of : Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan.
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 = GKL and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC