Class 2 Device Recall BD" MultiCheck CD4 Low Control

• Date Initiated by Firm: October 05, 2020
• Create Date: December 10, 2020
• Recall Status: Terminated on March 11, 2022
• Recall Number: Z-0562-2021
• Recall Event ID: 86655
• 510(K)Number: K150815
• Product Classification: Mixture, hematology quality control - Product Code JPK
• Product: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
• Code Information: Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US 349705 00382903497058 US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI 340914 00382903409143 OUS only 340915 00382903409150 OUS only 340916 00382903409167 OUS only
• FEI Number: 2916837
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Biosciences; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: Gail Griffiths; 410-316-4054
• Manufacturer Reason for Recall: Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
• FDA Determined Cause: Process control
• Action: On 10/13/2020, the firm notified it customer via telephone and sent an "URGENT MEDICAL DEVICE RECALL" Notification via email and/or FedEx to inform them that complaints have been report regarding their Low Control product which shows an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate gating with the potential for delayed patient management. Customer are instructed to: 1. Immediately review their inventory for the specific Catalog and lot numbers listed. Destroy all product subject to this recall following their institutions process for destruction. 2. Share this recall notification with all users of the product within their facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the Recalling Firm contact noted on the form. Even if customer do not have any of the affected lots in their inventory, they are asked to complete the Customer Recall Response Form indicating they have zero (0) quantity and return as indicated. Return Customer Response Form via email BDRC16@bd.com or fax 312-949-0371 Actions the Recalling Firm is taking: An investigation has been initiated to identify root cause and corrective actions to prevent recurrence. An questions, contact Customer/Technical Support at 877-232-8995 (prompt 2,2)
• Quantity in Commerce: 619 vials
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru.
• 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 = JPK