Device product
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Z-0032-2014
Product summary
- Event
- Event 66293
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23 kits
- Official record key
device-enforcement:Z-0032-2014
Official wording
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.
Code information: Lot 122822
Distribution pattern: US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
Derived failure modes
-
Unknown
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.