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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Recall Number Z-0775-2014
Classification Class II
Code Info PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
Product Distributed Qty 5
Reason For Recall Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

Event Detail

Event Id 67065
Product Type Devices
Status Ongoing
Recalling Firm Lab Vision Corporation
City Fremont
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.