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U.S. Department of Health and Human Services

Class 2 Device Recall Hypoguard Advance

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 Class 2 Device Recall Hypoguard Advancesee related information
Date Initiated by FirmNovember 26, 2003
Date PostedDecember 25, 2003
Recall Status1 Terminated 3 on November 21, 2005
Recall NumberZ-0275-04
Recall Event ID 27760
510(K)NumberK020232 
Product Classification Glucose Oxidase, Glucose - Product Code CGA
ProductHypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.
Code Information 01143A, 01023A, 01173A, 01293A, 01293B, 01303A 01303B, 02263A, 02263B, 02273A, 02273B, 02273C, 03113A, 11182A, 12282A, 12302A, 03113A, 03213A, 03263A, 03283A, 03283B, 04153A, 05293B, 04153B,  05293C, 04213A, 05293A, 04303A, 06063A, 05293D, and 05303A  
FEI Number 1832816
Recalling Firm/
Manufacturer		 Hypoguard USA, Inc.
5182 W 76th St
Edina MN 55439-2900
For Additional Information ContactBruce A. MacFarlane, Ph.D.
952-646-3188
Manufacturer Reason
for Recall		When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
FDA Determined
Cause 2		Other
ActionThe consignees were sent letters dated 11/26/03 which requested that the product be returned.
Quantity in Commerce10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221
DistributionThe product was distributed to consignees located nationwide in the United States.
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
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