ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-67
FDA device recall Z-0042-2008 · posted 2007-10-18 · Terminated
Recall details
- Recalling firm
- Esa Biosciences, Inc.
- Reason for recall
- Level 1 and Level 2 Control values were incorrectly assigned.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DOF
- Quantity affected
- 365 kits
- Distribution
- Nationwide and United Kingdom.
- Date initiated
- 2007-09-20
- Date posted
- 2007-10-18
- Date terminated
- 2008-03-25
- 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 II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |