Events

Recall of ESA LeadCare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Esa Biosciences, 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
    44909
  • Event Risk Class
    Class 3
  • Event Number
    Z-0043-2008
  • Event Initiated Date
    2007-09-20
  • Event Date Posted
    2007-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64512
  • 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
    lead test in vitro diagnostic - Product Code DOF
  • Reason
    Level 1 and level 2 control values were incorrectly assigned.
  • Action
    ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.

Device

ESA LeadCare
  • Model / Serial
    Lot number: 0704A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and United Kingdom.
  • Product Description
    ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A || Catalog Number: 70-7142
  • Manufacturer
    Esa Biosciences, Inc.

Manufacturer

Esa Biosciences, Inc.
  • Manufacturer Address
    Esa Biosciences, Inc., 22 Alpha Rd, Chelmsford MA 01824-4123
  • Source
    USFDA