Class 3 Device Recall BD Tritest CD3 FITC/CD PE/CD45 PerCP (IVD)

• Date Initiated by Firm: July 18, 2016
• Date Posted: August 09, 2016
• Recall Status: Terminated on March 01, 2017
• Recall Number: Z-2378-2016
• Recall Event ID: 74788
• 510(K)Number: K071143
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.
• Code Information: Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527, 30 September 2016; 54689 , 30 November 2016; 36715 , 31 December 2016; 15614, 31 January 2017; 57797, 28 February 2017.
• 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: Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.
• FDA Determined Cause: Labeling Change Control
• Action: BD Life Sciences sent an Urgent Product notification letter dated July 18, 2016 to all affected customers via UPS and/or e-mail. The letter informed the user of the issue and states that no action is required since product performance is not impacted. The response form is to be returned to BD as instructed. Customers requiring further assistance were instructed to contact BD Customer Support at 855-236-2772. For questions regarding this recall call 408-954-6080.
• Quantity in Commerce: 14,089
• Distribution: Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
• 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