Medical device recalls

Becton, Dickinson and Company, BD Biosciences recalls BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7…

Recall date
January 25, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0851-2016
FDA classification
Class III
Brand / firm
Becton, Dickinson and Company, BD Biosciences
Sold / distributed
Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.

Why it was recalled

Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.

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