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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Recall Number Z-1153-2013
Classification Class II
Code Info Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015
Product Distributed Qty 7433 cases
Reason For Recall Glucose test strips reports no result message when tested

Event Detail

Event Id 64638
Product Type Devices
Status Ongoing
Recalling Firm Nova Biomedical Corporation
City Waltham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-25
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.