Class 2 Device Recall AntiLambda APCH7

• Date Initiated by Firm: December 19, 2014
• Date Posted: January 20, 2015
• Recall Status: Terminated on March 11, 2016
• Recall Number: Z-1002-2015
• Recall Event ID: 70106
• Product Classification: Reagents,specific,analyte - Product Code MVU
• Product: Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
• Code Information: Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.
• Recalling Firm/ Manufacturer: BD Biosciences, Systems & Reagents; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: Eric Claussen; 408-954-6348
• Manufacturer Reason for Recall: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
• FDA Determined Cause: Vendor change control
• Action: BD sent a Recall notification letters dated December, 2014 to affected customers via Certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for affected lots, immediately remove affected reagents from their laboratory, request replacement product and complete and return the enclosed Tracking/Verification form, per the instructions. For questions contact BD Customer Support at 855-236-2772.
• Quantity in Commerce: 15 units
• Distribution: US Nationwide Distribution in the states of CA, NY, and MI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.