Biocare Medical, LLC recalls Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6…

Recall date

September 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0252-2016

FDA classification

Class II

Brand / firm

Biocare Medical, LLC

Sold / distributed

Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA, KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivia, Mexico, Indonesia and Australia.

Why it was recalled

Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.

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

What was recalled

Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.