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Recall Observatory FDA recall evidence

Device 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.

Z-0252-2016

September 08, 2015

Class II

Product summary

Firm
Biocare Medical, LLC
Event
Event 72160
Status
Terminated
Classification
Class II
Quantity
151 units
Official record key
device-enforcement:Z-0252-2016

Official wording

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

Code information: Catalog numbers: CME305A & CME305B: lots 110112, Expiry 11/2015;0 42213, expiry 4/2016; 101013, expiry 10/2016; 121813, expiry 12/2016; 070214, expiry 7/2017; 020215, expiry 2/2018. Catalog number: PME305AA, lots 070513, expiry 07/2016; 032114, expiry 3/2017, 030315, expiry 3/2018.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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