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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description 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
Classification Class III
Code Info Lot 122822
Product Distributed Qty 23 kits
Reason For Recall 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.

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
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