Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytome...
FDA Recall #Z-1002-2015 — Class II — December 19, 2014
Product Description
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Reason for Recall
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Recalling Firm
BD Biosciences, Systems & Reagents — San Jose, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 units
Distribution
US Nationwide Distribution in the states of CA, NY, and MI
Code Information
Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated