BD CD64 APC-R700 — Class II medical device recall Z-0334-2016
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2015-12-02, distributed in FL, GA, IA, IL, ND, PA, RI, TX…. Three lots of CD64 (MD22) are contaminated with CD4 antibody.
| Recall number | Z-0334-2016 |
|---|---|
| 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 | 2015-10-30 |
| Classified | 2015-11-24 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-05-27 |
| Distributed | FL, GA, IA, IL, ND, PA, RI, TX, WA |
| Quantity | 23 vials |
| Lot numbers | 4344945, 5037611, 5063945 |
| Model numbers | 657701 |
| Expiration dates | 2015-12-31 |
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 for recall
Three lots of CD64 (MD22) are contaminated with CD4 antibody.
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-0334-2016. 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.