Events

Recall of Device Recall AntiLambda APCH7

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BD Biosciences, Systems & Reagents.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70106
  • Event Risk Class
    Class 2
  • Event Number
    Z-1002-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132254
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Reagents,specific,analyte - Product Code MVU
  • Reason
    Two lots of the anti-lambda apc-h7 antibody are contaminated with cd38 antibody.
  • 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.

Device

Device Recall AntiLambda APCH7
  • Model / Serial
    Lot numbers 4155632 with expiry date of 2015-06-30.  Lot 42889687 was not shipped to customers.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, NY, and MI
  • Product Description
    Anti-Lambda APC-H7, Catalog Number 656157. || Product Usage: || Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

BD Biosciences, Systems & Reagents
  • Manufacturer Address
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA