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 Initiated
- August 27, 2015
- Posted
- September 24, 2015
- Terminated
- August 9, 2016
- Recall Number
- Z-2817-2015
- Quantity
- 128 units
- Firm Location
- San Jose, CA
Reason for Recall
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
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 / Code Info
Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.
Root Cause
Under Investigation by firm
Action Taken
Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.
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