CD79b PE — Class II medical device recall Z-0128-2017
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-10-26, distributed nationwide. CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
| Recall number | Z-0128-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2016-09-21 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2016-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 14 units |
| Lot numbers | 5348570 |
| Model numbers | 335816 |
| Expiration dates | 2017-07-31 |
Product
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen
Reason for recall
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
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-0128-2017. 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.