Smooth Muscle Action — Class II medical device recall Z-0252-2016
Terminated recall by Biocare Medical, LLC, reported 2015-11-18, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected
| Recall number | Z-0252-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Concord, CA, United States |
| Recall initiated | 2015-09-08 |
| Classified | 2015-11-09 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-01-11 |
| Distributed | AL, AZ, CA, CO, CT, DC, FL, GA, ID, KS, KY, LA, MA, MD, NC, NJ, NY, OH, OR, PA, SC, TX, UT |
| Countries outside the US | AU, BO, CA, CH, DE, ES, HU, ID, IN, IT, MX, SE, TR |
| Quantity | 151 units |
| Lot numbers | 020215, 030315, 032114, 070214, 070513, 101013, 110112, 121813, 42213 |
| Model numbers | 070513, 110112, CME305A, CME305A-0.1ML, CME305B, PME305AA |
| Expiration dates | 2015-11, 2016-04, 2016-07, 2016-10, 2016-12, 2017-03, 2017-07, 2018-02, 2018-03 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0252-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.