Events

Recall of Device Recall PSA 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-1631-2011
  • 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=96409
  • 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
    Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
  • 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 PSA ELISA Kit
  • Model / Serial
    Catalog number: BC-1019;  RN-34301 05-2010 RN-34353 05-2010 RN-34657 07-2010  RN-34877 07-2010 RN-35018 08-2010 RN-35057 08-2010  RN-35485 09-2010 RN-35699 10-2010 RN-35975 11-2010  RN-35976 11-2010 RN-36412 12-2010 RN-36523 12-2010  RN-36606 01-2011 RN-36821 02-2011 RN-37060 02-2011  RN-37370 03-2011 RN-37371 03-2011 RN-37603 02-2011  RN-37639 04-2011 RN-37645 04-2011 RN-37774 05-2011 RN-38040 06-2011 RN-38155 06-2011 RN-38178 07-2011  RN-38247 07-2011 RN-38913 08-2011 RN-39190 08-2011  RN-39219 08-2011 RN-39250 09-2011 RN-39529 10-2011  RN-39703 11-2011 RN-39833 11-2011 RN-39960 12-2011  RN-39963 12-2011 RN-40108 12-2011 RN-40109 12-2011  RN-40261 12-2011 RN-40340 02-2012 RN-40435 02-2012  RN-40585 03-2012 RN-40586 03-2012 RN-40791 03-2012 RN-40909 03-2012 RN-40915 03-2012 RN-41193 05-2012  RN-41293 05-2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    PSA 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