Events

Recall of Device Recall CD99

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
    70823
  • Event Risk Class
    Class 2
  • Event Number
    Z-1535-2015
  • Event Initiated Date
    2015-03-17
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134965
  • 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
    A drop in staining intensity over time has been observed. these lots may not meet their labeled shelf life.
  • Action
    Biocare sent a Medical Device Notification letters dated March 17, 2015 to all affected sites. The letters identify the affected product, problem, actions to be taken and the fact that it affects all identified lots shipped between 02/13/13 and / 01/28/15. The letters instructed customers to immediately discontinue further use of the recalled lots, dispose of them according to state and local regulations and complete the response form and returned by April 7, 2015. Credit will be issued upon receipt of the response form.

Device

Device Recall CD99
  • Model / Serial
    Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.
  • Product Description
    CD99 || Catalog number PM008 AA; || For In Vitro Diagnostic Use. || Product Usage: || Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
  • 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