Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2020 - (Recall #: Z-0562-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Product Classification:

Class II

Date Initiated: October 5, 2020

Date Posted: December 16, 2020

Recall Number: Z-0562-2021

Event ID: 86655

Reason for Recall:

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

Status: Terminated

Product Quantity: 619 vials

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated