FDA Device recall Z-2817-2015
CD4 (SK3), FITC
- FDA Device
- Class III
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class III recall of CD4 (SK3), FITC by Becton Dickinson And Bd Biosciences, citing CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2817-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-08-27 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
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).
Reason
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Identifiers
| code_info | Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2817-2015%22
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