BD Biosciences Recalls Contaminated Anti-Lambda APC-H7 Antibody Lots
BD Biosciences is recalling two lots of Anti-Lambda APC-H7 antibody due to contamination with CD38 antibody. The product is used for in vitro flow cytometric immunophenotyping.
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 contamination with another antibody, which is a quality control issue rather than a high-risk pathogen or structural defect, fitting the criteria for moderate severity.
Plain-English summary
BD Biosciences, Systems & Reagents is recalling two lots of the Anti-Lambda APC-H7 antibody, Catalog Number 656157. The recall involves 15 units of the product, which is intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
The recall was initiated because the two lots are contaminated with CD38 antibody. The affected lot numbers are 4155632 (with an expiry date of 2015-06-30) and 42889687. The source text notes that Lot 42889687 was not shipped to customers.
The product was distributed nationwide in the United States, specifically in the states of California, New York, and Michigan. Users of this product should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
- Manufacturer
- BD Biosciences, Systems & Reagents
- Hazard
- Affected units
- 15
Distribution
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