Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml Recalled by Biocare Medical, LLC Due to Certain catalog numbers and lots of Smooth Muscle...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biocare Medical, LLC directly.
Affected Products
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.
Quantity: 151 units
Why Was This Recalled?
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Where Was This Sold?
This product was distributed to 23 states: AL, AZ, CA, CO, CT, FL, GA, ID, KS, KY, LA, MD, MA, NJ, NY, NC, OH, OR, PA, SC, TX, UT, DC
About Biocare Medical, LLC
Biocare Medical, LLC has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report