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Bio-Rad Laboratories recalls FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Micr
Recalled October 30, 2013 · FDA recall Z-0032-2014 · 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. · FDA Class III
Units
23 kits
Sold at
US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
Description
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.
Product
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Manufacturer(s)
Bio-Rad Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →