Medical device recalls Moderate risk

BD Biosciences, Systems & Reagents recalls CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

Recall date
March 23, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1375-2015
FDA classification
Class II
Brand / firm
BD Biosciences, Systems & Reagents
Sold / distributed
US Distribution in states of: MO, GA, AZ, NE, TX, VA

Why it was recalled

One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may 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

CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

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