Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-0252-2016

U.S. FDA — Device Enforcement · United States · 2015-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0252-2016
Date of alert: 2015-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biocare Medical, LLC
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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