Events

Recall of Device Recall CEA ELISA Kit

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

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
    57506
  • Event Risk Class
    Class 2
  • Event Number
    Z-1627-2011
  • Event Initiated Date
    2010-12-22
  • Event Date Posted
    2011-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96401
  • 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
    System, test, carcinoembryonic antigen - Product Code DHX
  • Reason
    Product labels indicate that the products are for ivd use and they do not have an approved 510(k).
  • Action
    The firm, BioCheck, sent an "URGENT: DEVICE RECALL" letter dated December 22, 2010 to all customers. The letter described the product, problem and actions to be taken by customers. The customer were instructed to examine their inventory for the affected lots, if found, discontinue distributing the lots and promptly return via Fedex to BioCheck at 323 Vintage Park Drive, Foster City, CA 94404, Attn: RETURNED GOODS; immediately contact their accounts, if they further distributed the product, and inform them of the Recall, and complete and return the response form via email at: info@biocheck.com or fax to (650-573-1969) immediately. If you have any questions, please call (650) -573-1968 anytime during office hours (8:30am to 5:30pm Pacific time).

Device

Device Recall CEA ELISA Kit
  • Model / Serial
    Catalog number: BC-1011;  RN-33968 04-2010 RN-34421 06-2010 RN-34473 06-2010  RN-34853 07-2010 RN-35157 08-2010 RN-35486 08-2010  RN-35815 09-2010 RN-36179 12-2010 RN-36221 12-2010  RN-36751 02-2011 RN-37124 02-2011 RN-37125 02-2011  RN-37892 05-2011 RN-37953 02-2011 RN-38320 07-2011  RN-38307 07-2011 RN-39144 08-2011 RN-39416 10-2011  RN-39417 10-2011 RN-40110 12-2011 RN-40464 12-2011  RN-40982 04-2012 RN-41177 04-2012.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    CEA ELISA Kit. || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
  • Manufacturer
    BioCheck Inc

Manufacturer

BioCheck Inc
  • Manufacturer Address
    BioCheck Inc, 323 Vintage Park Dr, Foster City CA 94404-1186
  • Manufacturer Parent Company (2017)
    Origene Technologies Inc
  • Source
    USFDA