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U.S. Department of Health and Human Services

Class 2 Device Recall SeNova Blood Glucose Test Strips

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  Class 2 Device Recall SeNova Blood Glucose Test Strips see related information
Date Initiated by Firm March 14, 2005
Date Posted September 15, 2005
Recall Status1 Terminated 3 on January 23, 2007
Recall Number Z-1546-05
Recall Event ID 32883
510(K)Number K032076  
Product Classification Glucose Dehydrogenase, Glucose - Product Code LFR
Product SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
Code Information Lot numbers: 407061, 4071601, 4071901, 4071902, 4072001, 4072002, 4072201, 4072202, 4072801, 4072802, 4072901, 4072902, 4073001; 4080301, 4080302, 4080303, 4080401, 4080402, 4080601, 4081101, 4081102, 4081601, 4081901, 4082001, 4082002, 4082301, 4082501, 4082502, 4082701, 4083101, 4083102, 4090101, 4090201, 4091601, 4091702, 4092101, 4092201, 4092301, 4092401, 4092701, 4092801, 4092901, 4100101, 4100401, 4100402, 4100501, 4100601, 4101101, 4101201, 4101301, 4101401, 4101801, 4102201, 4102502, 4102601, 4102701, 4102801, 4102901, 4110401, 4110501, 4111101, 4111601 and 4111602.
Recalling Firm/
Manufacturer		 CHdiagnostics
1 Carlson Pkwy N
Plymouth MN 55447-4440
For Additional Information Contact John A. Murray
952-476-9007 Ext. 13
Manufacturer Reason
for Recall		 A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
FDA Determined
Cause 2		 Other
Action Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.
Quantity in Commerce 43,138 vials
Distribution AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.
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 = LFR and Original Applicant = CHDIAGNOSTICS LLC
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