Recall Z-0252-2016— Biocare Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Biocare Medical, LLC, initiated 2015-09-08, terminated 2016-01-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA..
- Recalling firm
- Biocare Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-08
- Terminated
- 2016-01-11
- Firm location
- Concord, CA, United States
Product description
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.
Reason for recall
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.