Recall Z-0252-2016
Biocare Medical, LLC · initiated September 8, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
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: Device Design
Action taken
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.
Details
- Recall number
- Z-0252-2016
- Initiated
- September 8, 2015
- Posted by FDA
- November 9, 2015
- Terminated
- January 11, 2016
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 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.
- Recalling firm
- Biocare Medical, LLC, Concord, CA