BD CD56 PE Cy 7 Reagent Recalled for Unexpected Staining Patterns
Becton, Dickinson and Company is recalling three lots of CD56 PE Cy 7 reagent because they contain a low amount of HLA-DR PE antibody, which could result in an unexpected staining pattern.
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, but the hazard is a low amount of antibody causing unexpected staining patterns rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity issue.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling three lots of the CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809. The affected lots are 4300708, 4304864, and 5013643, all with an expiry date of 31 OCT 2015. A total of 362 units were distributed in the United States and internationally to Taiwan.
The recall was initiated because the product contains a low amount of HLA-DR PE antibody. This issue could result in an unexpected staining pattern when the reagent is used. The CD56 antigen is involved in homophilic adhesion in neurons and NK cells.
Users of this product should check their inventory for the specific catalog and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 362
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 (5)
- Catalog number 335809
- Lot numbers 4300708
- 4304864
- 5013643
- all with expiry dates of 31 OCT 2015
Distribution
Distribution scope not specified by the agency.
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