FDA-Device2013-10-30Class III
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Bio-Rad Laboratories
Hazard
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.
Sold states
US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
Affected count
23 kits
Manufactured in
6565 185th Ave NE, N/A, Redmond, WA, United States
Products
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0032-2014Don't want to check this manually?
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