Known Identifiers & Locations
FEI Numbers
1218996
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0042-2008 |
ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A
Catalog Number: 70-6762
Reason: Level 1 and Level 2 Control values were incorrectly assigned.
|
2007-09-20 |
Terminated
|
View Details
|
| Z-0043-2008 |
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
Reason: Level 1 and Level 2 Control values were incorrectly assigned.
|
2007-09-20 |
Terminated
|
View Details
|
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