Recall Z-0252-2016 ยท NJT Immunohistochemistry Reagents And Kits
Biocare Medical, LLC
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 repor
| Date | Nov 9, 2015 (initiated Sep 8, 2015) |
| Status | Terminated |
| Reason | Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.