Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

FDA Recall Z-1002-2015 · Posted 2015-01-20

Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeMVU
Date Initiated2014-12-19
Date Terminated2016-03-11
Product Quantity15 units

Reason for Recall

Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

Firm 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.

Root Cause

Vendor change control

Distribution Pattern

US Nationwide Distribution in the states of CA, NY, and MI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑