Recall Z-0914-05 ยท DOF Lead, Atomic Absorption
Esa Biosciences, Inc.
LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
| Date | Jun 21, 2005 (initiated May 19, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM Esa, Inc., Sep 9, 1997 |