Class 3 Device Recall BD ReticCount" Reticulocyte Reagent System

• Date Initiated by Firm: March 18, 2016
• Create Date: April 14, 2016
• Recall Status: Terminated 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/ Manufacturer: Becton, Dickinson and Company, BD Biosciences; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: Melissa J. Quinn; 408-954-6080
• 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: 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