Events

Recall of Device Recall HSV1 IgG 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-1639-2011
  • 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=96441
  • 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
    Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
  • 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 HSV1 IgG ELISA kit
  • Model / Serial
    Catalog number: BC-1093: RN-33786 03-2010 RN-33956 03-2010 RN-34538 03-2010  RN-35037 08-2010 RN-35242 09-2010 RN-36114 12-2010  RN-37937 03-2011 RN-38809 07-2011 RN-38839 06-2011  RN-39279 09-2011 RN-40515 02-2012 RN-40515A 02-2012  N-40833 02-2012 RN-40835 02-2012 RN-41271 02-2012  RN-41301 02-2012 RN-41357 02-2012;  Catalog number BC-1095:  RN-33990 04-2010 RN-34548 02-2010 RN-34904 04-2010  RN-35427 09-2010 RN-35807 10-2010 RN-35889 10-2010  RN-37713 03-2011 RN-38218 04-2011 RN-38875 07-2011  RN-39471 10-2011 RN-40226 10-2011 RN-40226A 10-2011  RN-40516 03-2012 RN-40942 03-2012 RN-41214 03-2012.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    HSV-1 IgG ELISA kit ; || HSV-1 IgM 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