Events

Recall of Device Recall D240 (Lymphatic Marker)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biocare Medical, LLC.

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
    71229
  • Event Risk Class
    Class 3
  • Event Number
    Z-1676-2015
  • Event Initiated Date
    2015-05-06
  • Event Date Posted
    2015-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136887
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Reason
    Firm discovered that incorrect instructions for use were shipped with one lot of d2-40.
  • Action
    Biocare Medical sent a Medical Device Notification letter dated May 6, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete all actions listed on the enclosed Return Response Form.

Device

Device Recall D240 (Lymphatic Marker)
  • Model / Serial
    Catalog number: PM266AA, lot 030615, Expiration: 2018/03.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
  • Product Description
    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; || Catalog number: PM266AA || Product Usage: || In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
  • Manufacturer
    Biocare Medical, LLC

Manufacturer

Biocare Medical, LLC
  • Manufacturer Address
    Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
  • Manufacturer Parent Company (2017)
    Biocare Medical LLC
  • Source
    USFDA