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.
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