Date Initiated by Firm |
November 02, 2007 |
Date Posted |
February 16, 2008 |
Recall Status1 |
Terminated 3 on December 09, 2008 |
Recall Number |
Z-0725-2008 |
Recall Event ID |
45815 |
510(K)Number |
K070068
|
Product Classification |
Ion Based Enzymatic Electrode (Creatinine) - Product Code CGL
|
Product |
Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 |
Code Information |
Lot Numbers: 4207225241 and 4207261241 |
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 |
300 units |
Distribution |
Nationwide Distribution, including the state of NY |
Total Product Life Cycle |
TPLC Device Report
|
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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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