Device 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).
Z-2817-2015
Product summary
- Event
- Event 72071
- Status
- Terminated
- Classification
- Class III
- Quantity
- 128 units
- Official record key
device-enforcement:Z-2817-2015
Official wording
Reason: CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
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.
Derived failure modes
-
Labeling or packaging
label contains an error