FDA Medical Device Recalls (openFDA)
Esa Biosciences, Inc.: LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
- Recall number
- Z-0914-05
- Recalling firm
- Esa Biosciences, Inc.
- Product
- LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
- Status
- Terminated
- Initiated
- 2005-05-19
- Posted
- 2005-06-21
- Terminated
- 2005-11-21
- Reason
- Lead test results may be reported lower than the actual value
- Root cause
- Other
- 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
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- K971640
- 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