Company: Bio-Rad Laboratories
Date of Enforcement Report: 10/30/2013
Class lIl:
PRODUCT
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Recall Number Z-0032-2014
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.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Redmond, WA on 8/20/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
23 kits
DISTRIBUTION
Nationwide
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