Known Identifiers & Locations
FEI Numbers
2623532
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 (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0023-2007 |
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Reason: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
|
2006-09-07 |
Terminated
|
View Details
|
| Z-0024-2007 |
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Reason: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
|
2006-09-07 |
Terminated
|
View Details
|
| Z-0025-2007 |
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Reason: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
|
2006-09-07 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.