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U.S. Department of Health and Human Services

Class 2 Device Recall LeadCare

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  Class 2 Device Recall LeadCare see related information
Date Initiated by Firm May 19, 2005
Date Posted June 21, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0914-05
Recall Event ID 32066
510(K)Number K971640  
Product Classification Lead, Atomic Absorption - Product Code DOF
Product LeadCare Blood Lead Testing System Kits
Catalog Number: 70-2233
Code Information 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 
Recalling Firm/
Esa Biosciences, Inc.
22 Alpha Rd
Chelmsford MA 01824-4123
For Additional Information Contact harold Asp
Manufacturer Reason
for Recall
Lead test results may be reported lower than the actual value
FDA Determined
Cause 2
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.
Quantity in Commerce 14,760 test kits
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DOF and Original Applicant = ESA, INC.