BD Biosciences Recalls CD123 PE Reagent Due to Antibody Contamination
BD Biosciences is recalling one lot of CD123 PE reagent because it contains a low amount of CD4 antibody, which may result in unexpected staining patterns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard involves potential inaccurate test results (unexpected staining patterns) rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling issues.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling one lot of CD123 (9F5) PE Analyte Specific Reagent (Catalog number 649453). The recall involves 9 units of the product, identified by Lot 5008762 with an expiration date of 11/30/16.
The recall was initiated because the product was determined to contain a low amount of CD4 antibody. This contamination may result in an unexpected staining pattern when the reagent is used.
The affected product was distributed in the United States in the states of Missouri, Georgia, Arizona, Nebraska, Texas, and Virginia. Users of the product should stop using the affected lot and contact the manufacturer for further instructions.
The recalled product
- Product
- CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
- Manufacturer
- BD Biosciences, Systems & Reagents
- Affected units
- 9
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 5008762
- Exp 11/30/16.
Distribution
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