Biocare Medical Recalls Smooth Muscle Actin Immunohistochemistry Reagents
Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracy without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biocare Medical, LLC is recalling 151 units of Smooth Muscle Actin (SMA) Immunohistochemistry reagents. The affected products include catalog numbers CME305A, CME305B, and PME305AA in various lot numbers and sizes. These reagents are intended for use in immunohistochemistry to identify tumors arising from smooth muscle and myoepithelial cells.
The recall was initiated because certain catalog numbers and lots of the Smooth Muscle Actin reagent may stain some cell types that are typically expected to be negative for SMA. This potential for incorrect staining could affect the accuracy of diagnostic results.
The affected units were distributed worldwide, including in the United States and internationally to countries such as Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivia, Mexico, Indonesia, and Australia. Users of these reagents should stop using the affected lots and contact Biocare Medical for further instructions.
The recalled product
- 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
- Manufacturer
- Biocare Medical, LLC
- Affected units
- 151
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
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