FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-2817-2015
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- 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).
- Status
- Terminated
- Initiated
- 2015-08-27
- Posted
- 2015-09-24
- Terminated
- 2016-08-09
- 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.
- Lot, serial or model codes
- Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.
- 510(k) numbers
- ["K900802"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28