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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015 Class II Glucose test strips reports no result message when tested 7433 cases Z-1153-2013
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015 Class II Glucose test strips reports no result message when tested 2200 cases Z-1154-2013
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