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U.S. Department of Health and Human Services

Class 2 Device Recall Nova StatStrip Glucose Test Strips

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 Class 2 Recall
Nova StatStrip Glucose Test Strips
see related information
Date Posted April 19, 2013
Recall Status1 Terminated on September 26, 2014
Recall Number Z-1153-2013
Recall Event ID 64638
Premarket Notification
510(K) Number
K063821 
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Code Information Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015
Recalling Firm/
Manufacturer
Nova Biomedical Corporation
200 Prospect St
Waltham, Massachusetts 02453
For Additional Information Contact Paul MacDonald
781-647-3700 Ext. 211
Manufacturer Reason
for Recall
Glucose test strips reports no result message when tested
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unused boxes of the Nova StatStrip Glucose Test Strip lots indicated from all locations within your institute; RETURN all unused boxes of the Nova StatStrip Glucose Test Strips lots indicated to Nova Biomedical U.K. or your local Nova distributor following the country specific instructions provided by your authorized Nova representative, and complete and return the Fax-Back Form via email or FAX to your Regional Service Manager at 781-8914806. On April 08, 2013, the firm expanded the recall notification to include one additional test strip lot #0313021309 which was shipped under two catalog numbers(Catalog # 42214 and Catalog# 51493). US Notification by phone contact with key customer contact facilitated by Senior Manger of Technical Support Services. International - Field Safety Notice and Faxback Form is being communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). Questions regarding this notice should be directed to the following Nova Biomedical EU Authorized Representative at: Nova Biomedical Innovation House, Aston Lane South Runcorn,WA7 3FY Telephone: + 44 1244 287087 Email: Europe@novabiomedical.co.uk. or US at (781) 894-0800.
Quantity in Commerce 7433 cases
Distribution Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = NOVA BIOMEDICAL CORP.
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