Recall Z-2817-2015— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-2817-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-27

Class III · Terminated

Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2015-08-27, terminated 2016-08-09. It names one FDA 510(k) clearance: K900802. Product: 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).. Reason: CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class III
Status: Terminated
Initiated: 2015-08-27
Terminated: 2016-08-09
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K900802 — ANTI-HUMAN LEU-3A (CD4) FITCBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1990-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.