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U.S. Department of Health and Human Services

Class 2 Device Recall EZCHEM Linearity Pack

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  Class 2 Device Recall EZCHEM Linearity Pack see related information
Date Initiated by Firm November 02, 2007
Date Posted February 16, 2008
Recall Status1 Terminated 3 on December 09, 2008
Recall Number Z-0726-2008
Recall Event ID 45815
510(K)Number K070068  
Product Classification Ion Based Enzymatic Electrode (Creatinine) - Product Code CGL
Product Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
Code Information Lot Numbers: 4307236990 and 4307270990 
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453
For Additional Information Contact Paul W. MacDonald
781-894-0800 Ext. 211
Manufacturer Reason
for Recall		 Incorrect Results - Creatinine results were lower than the laboratory reference method.
FDA Determined
Cause 2		 Device Design
Action Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.
Quantity in Commerce 286 units
Distribution Nationwide Distribution, including the state of NY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGL and Original Applicant = NOVA BIOMEDICAL CORP.
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