Recall Z-2817-2015 ยท GKZ Counter, Differential Cell
Becton, Dickinson and Company, BD Biosciences
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).
| Date | Sep 24, 2015 (initiated Aug 27, 2015) |
| Status | Terminated |
| Reason | CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. |
| Root cause | Under Investigation by firm |
| Action | Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail. |
| Quantity | 128 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900802 | ANTI-HUMAN LEU-3A (CD4) FITC Bd Becton Dickinson Vacutainer Systems Preanalytic, May 15, 1990 |