Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2015 - (Recall #: Z-2817-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

Product Classification:

Class III

Date Initiated: August 27, 2015

Date Posted: September 30, 2015

Recall Number: Z-2817-2015

Event ID: 72071

Reason for Recall:

CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

Status: Terminated

Product Quantity: 128 units

Code Information:

Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.

Distribution Pattern:

Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.

Voluntary or Mandated:

Voluntary: Firm initiated