Esa Biosciences, Inc. LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
Brand
Esa Biosciences, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Esa Biosciences, Inc. is recalling LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233 due to Lead test results may be reported lower than the actual value. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lead test results may be reported lower than the actual value
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026