Class 3 Device Recall BD MultiCheck CD4 Low Control

• Date Initiated by Firm: July 18, 2014
• Date Posted: August 14, 2014
• Recall Status: Terminated on May 19, 2015
• Recall Number: Z-2233-2014
• Recall Event ID: 68892
• 510(K)Number: K982231
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
• Code Information: Catalog number 340916; Lot number BM084L
• Recalling Firm/ Manufacturer: BD Biosciences, Systems & Reagents; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: Eric Claussen; 408-954-6348
• Manufacturer Reason for Recall: The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02
• FDA Determined Cause: Labeling mix-ups
• Action: Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem.
• Quantity in Commerce: 85
• Distribution: IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium
• 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 = GKZ and Original Applicant = R & D SYSTEMS, INC.