FDA Device recall Z-0334-2016
BD CD64 APC-R700
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of BD CD64 APC-R700 by Becton Dickinson And Bd Biosciences, citing three lots of CD64 (MD22) are contaminated with CD4 antibody.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0334-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-30 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | FL, GA, IA, IL, ND, PA, RI, TX, WA |
Product
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
Reason
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
Identifiers
| code_info | Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 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-0334-2016%22
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