FDA Medical Device Recalls (openFDA)
Esa Biosciences, Inc.: ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
- Recall number
- Z-0043-2008
- Recalling firm
- Esa Biosciences, Inc.
- Product
- ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
- Status
- Terminated
- Initiated
- 2007-09-20
- Posted
- 2007-10-18
- Terminated
- 2008-03-25
- Reason
- Level 1 and Level 2 Control values were incorrectly assigned.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 2 kits
- Distribution
- Nationwide and United Kingdom.
- Lot, serial or model codes
- Lot number: 0704A
- 510(k) numbers
- ["K052549"]
- PMA numbers
- not on file
- Product code
- DOF
- Firm FEI
- 1218996
- Firm city
- Chelmsford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28