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U.S. Department of Health and Human Services

Class 2 Device Recall Smooth Muscle Actin (SMA) antibody

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  Class 2 Device Recall Smooth Muscle Actin (SMA) antibody see related information
Date Initiated by Firm September 08, 2015
Date Posted November 09, 2015
Recall Status1 Terminated 3 on January 11, 2016
Recall Number Z-0252-2016
Recall Event ID 72160
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
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.
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.
Recalling Firm/
Manufacturer		 Biocare Medical, LLC
4040 Pike Ln
Concord CA 94520-1227
For Additional Information Contact Scott Huntsman
925-603-8033
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Biocare sent a Medical Device Recall Notification letter dated September 8, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue and dispose of all affected product. Customers were asked to complete an return the enclosed Return Response Form. Customer's accounts would be credited for all affected product. For questions regarding this recall call 925-603-8033.
Quantity in Commerce 151 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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