CD4 — Class III medical device recall Z-2817-2015
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2015-09-30, distributed nationwide. CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
| Recall number | Z-2817-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2015-08-27 |
| Classified | 2015-09-24 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2016-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CL, CN, CO, JP, NZ, TW |
| Quantity | 128 units |
| Reason classes | labeling |
| Lot numbers | 5112711 |
| Model numbers | 340133 |
| Expiration dates | 2016-11-30 |
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 for recall
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2817-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.