Medical device recalls Moderate risk

Becton, Dickinson and Company, BD Biosciences recalls BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes ho…

Recall date
July 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2453-2015
FDA classification
Class II
Brand / firm
Becton, Dickinson and Company, BD Biosciences
Sold / distributed
US Distribution and Internationally to Taiwan.

Why it was recalled

Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.

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 CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.

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