Reported Nov 18, 2015 · Terminated
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA -…
Biocare Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocare Medical, LLC · 4040 Pike Ln · Concord, CA · 94520-1227
Is this the product you have?
- Smooth Muscle Action (SMA) Immunohistochemistry reagent
- Catalog numbersCME305A-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
- Lot codes and dates
- Catalog numbersCME305A &
- CME305B
lots 110112Expiry 11/20150 42213expiry 4/2016101013expiry 10/2016121813expiry 12/2016070214expiry 7/2017020215expiry 2/2018
- Catalog number
PME305AAlots 070513expiry 07/2016032114expiry 3/2017030315expiry 3/2018
- Amount recalled
- 151 units
Where it was sold
Why it was recalled
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
This product could cause temporary or reversible health problems — stop using it.
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