Known Identifiers & Locations
FEI Numbers
3008272466
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 (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0032-2014 |
FSE Image Upgrade Kit, Catalog # 92019C
This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Reason: The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA
Quantitative Determination in EVOLIS APF version 6.0.
|
2013-08-20 |
Terminated
|
View Details
|
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