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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 Device Recall Nova StatStrip Glucose Test Strips see related information
Date Initiated by Firm February 12, 2010
Date Posted June 10, 2010
Recall Status1 Terminated 3 on July 22, 2011
Recall Number Z-1783-2010
Recall Event ID 54630
510(K)Number k060345  k063821  k070960  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454.

Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.
Code Information Lot Number: 0309019249, Expiration Date: 1/31/2011. 
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453
For Additional Information Contact
781-894-0800 Ext. 211
Manufacturer Reason
for Recall		 Glucose strips report low glucose results
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.
Quantity in Commerce 392 Cases (1800 strips each)
Distribution Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
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 = CGA and Original Applicant = NOVA BIOMEDICAL CORP.
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