FDA Device recall Z-0128-2017
CD79b PE (ASR) , Catalog number 335816
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of CD79b PE (ASR) , Catalog number 335816 by Becton Dickinson And Bd Biosciences, citing CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0128-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-21 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
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
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity
Identifiers
| code_info | Lot number: 5348570; Expiration Date: 31 July 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0128-2017%22
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