Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Nova StatStrip Glucose Test Strips

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Nova StatStrip Glucose Test Stripssee related information
Date Initiated by FirmFebruary 12, 2010
Date PostedJune 10, 2010
Recall Status1 Terminated 3 on July 22, 2011
Recall NumberZ-1783-2010
Recall Event ID 54630
510(K)NumberK060345 K063821 K070960 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductNova 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
ActionNova 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 Commerce392 Cases (1800 strips each)
DistributionWorldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
-
-