LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
FDA device recall Z-0914-05 · posted 2005-06-21 · Terminated
Recall details
- Recalling firm
- Esa Biosciences, Inc.
- Reason for recall
- Lead test results may be reported lower than the actual value
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DOF
- Quantity affected
- 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
- Date initiated
- 2005-05-19
- Date posted
- 2005-06-21
- Date terminated
- 2005-11-21
- Location
- Chelmsford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEADCARE BLOOD LEAD TESTING SYSTEM (K971640) | Esa, Inc. | 1997-09-09 |