Recall Z-0043-2008 ยท DOF Lead, Atomic Absorption
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
| Date | Oct 18, 2007 (initiated Sep 20, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM Esa Biosciences, Inc., Oct 6, 2005 |