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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CGA
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