BD Biosciences Recalls Contaminated CD79b PE Antibody Reagent
Becton, Dickinson and Company is recalling 14 units of CD79b PE antibody reagent due to contamination with a FITC conjugate of unknown specificity.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The hazard is contamination with an unknown conjugate, which is a quality issue rather than a direct physical injury risk.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling 14 units of CD79b PE (ASR) antibody reagent, Catalog number 335816. The product is a hematology reagent used to detect the CD79b antigen, a component of immunoglobulin antigen receptors.
The recall was initiated because the product is contaminated with a FITC conjugate of unknown antigenic specificity. This contamination could potentially affect the accuracy of laboratory test results.
The affected lot number is 5348570, with an expiration date of 31 July 2017. The product was distributed nationwide to California, Minnesota, Ohio, and Texas. Users of this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 14
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 (2)
- Lot number: 5348570
- Expiration Date: 31 July 2017
Distribution
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