Esa Biosciences, Inc. ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762
Brand
Esa Biosciences, Inc.
Lot Codes / Batch Numbers
Lot number: 0704A
Products Sold
Lot number: 0704A
Esa Biosciences, Inc. is recalling ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A C due to Level 1 and Level 2 Control values were incorrectly assigned.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Level 1 and Level 2 Control values were incorrectly assigned.
Recommended Action
Per FDA guidance
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.
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