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).
FDA Recall Z-2817-2015 · Posted 2015-09-24
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Recalling FirmBecton, Dickinson and Company, BD Biosciences
Recall StatusTerminated
Product CodeGKZ
Date Initiated2015-08-27
Date Terminated2016-08-09
Product Quantity128 units
Reason for Recall
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Firm Action
Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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