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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 66293
Product Type Devices
Status Ongoing
Recalling Firm Bio-Rad Laboratories
City Redmond
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-20
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. Lot 122822 Class III 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. 23 kits Z-0032-2014
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