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U.S. Department of Health and Human Services

Class 3 Device Recall ESA LeadCare

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 Class 3 Device Recall ESA LeadCaresee related information
Date Initiated by FirmSeptember 20, 2007
Date PostedOctober 18, 2007
Recall Status1 Terminated 3 on March 25, 2008
Recall NumberZ-0043-2008
Recall Event ID 44909
510(K)NumberK052549 
Product Classification lead test in vitro diagnostic - Product Code DOF
ProductESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
Code Information Lot number: 0704A 
Recalling Firm/
Manufacturer		 Esa Biosciences, Inc.
22 Alpha Rd
Chelmsford MA 01824-4123
For Additional Information ContactHarol Asp
978-250-7000
Manufacturer Reason
for Recall		Level 1 and Level 2 Control values were incorrectly assigned.
FDA Determined
Cause 2		Process design
ActionESA 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.
Quantity in Commerce2 kits
DistributionNationwide and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DOF
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