Events

Recall of Device Recall Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST 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
    56291
  • Event Risk Class
    Class 2
  • Event Number
    Z-2243-2010
  • Event Initiated Date
    2010-07-15
  • Event Date Posted
    2010-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93149
  • 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
    ELISA TEST KIT - Product Code NUK
  • Reason
    Products were marketed without 510(k) for diagnostic use. unapproved device.
  • Action
    BioCheck sent an "Urgent Device Recall" letter dated July 15, 2010 to consignees identifying the products as unapproved and requesting prompt return to the firm. Consignees are asked to sub-recall. The letter requested a reponse form be completed and returned to the firm. Diagnostic claims have been removed from the website. Returned product will be quarantined by the firm pending determination of marketing status and labeling revision.

Device

Device Recall Human Cardiac Specific Fatty AcidBinding Protein (HFABP) ELISA TEST KIT
  • Model / Serial
    Catalog #/Product # BC-1123 Kit lot numbers: RN-27940, 33689, and 37260
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.
  • Product Description
    Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.
  • 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