Events

Recall of Device Recall 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
    32066
  • Event Risk Class
    Class 2
  • Event Number
    Z-0914-05
  • Event Initiated Date
    2005-05-19
  • Event Date Posted
    2005-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39067
  • 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, Atomic Absorption - Product Code DOF
  • Reason
    Lead test results may be reported lower than the actual value.
  • Action
    ESA is notifying beginning 5/19/05 to Distributors and End Users by letter sent First Class Mail. Additionally Distributors may be notified by phone to ensure receipt of letter. Customers will be asked to return product to ESA for destruction. A fax back form is included with the notification letter. Customers will fax back the number of Test Kits that they require replacement for. ESA will ship replacement kits and include a prepaid return shipping label for the customer to return defective kits to ESA.

Device

Device Recall LeadCare
  • Model / Serial
    Lot CA6 Expiration date 2/5/05 Lot CA7 Expiration date 2/06/05 Lot CA8 Expiration date 5/18/05 Lot CA9 Expiration date 10/5/05 Lot CCA Expiration date 12/11/05 Lot CCE Expiration date 6/17/06 Lot CCF Expiration date 7/11/06 Lot CCH Expiration date 7/12/06
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States Foreign: Mexico, Canada, Indonesia, Palestine, Kingdom of Saudi Arabia, Columbia, Switzerland, Romania, West Indies, Italy, Japan, Turkey, United Kingdom, Phillipines, Singapore, Jamaica, Uraguay, South Korea, Peru, Tanzia, South Africa, Quatar, Croatia, Zambia, China, Germany
  • Product Description
    LeadCare Blood Lead Testing System Kits || Catalog Number: 70-2233
  • Manufacturer
    Esa Biosciences, Inc.

Manufacturer

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