Events

Recall of Device Recall CA199 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-1630-2011
  • 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=96407
  • 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, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
  • 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 CA199 ELISA Kit
  • Model / Serial
    Catalog number: BC-1017;  RN-34237 05-2010 RN-33400 02-2010 RN-34586 05-2010  RN-34850 05-2010 RN-35131 08-2010 RN-35474 09-2010  RN-35854 09-2010 RN-36593 01-2011 RN-37142 03-2011  RN-37903 04-2011 RN-39461 09-2011 RN-40394 02-2012  RN-40916 04-2012.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    CA19-9 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