The Recall Desk
ModerateFDA (Devices)·Z-1002-2015·Announced 2015-01-28

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.

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. 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.
Affected units
15

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: