Medical device recalls Moderate risk

Becton, Dickinson and Company, BD Biosciences recalls BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as an…

Recall date
October 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0334-2016
FDA classification
Class II
Brand / firm
Becton, Dickinson and Company, BD Biosciences
Sold / distributed
Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.

Why it was recalled

Three lots of CD64 (MD22) are contaminated with CD4 antibody.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

Get recall alerts

Free email alert whenever Becton, Dickinson and Company, BD Biosciences has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Becton, Dickinson and Company, BD Biosciences