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U.S. Department of Health and Human Services

Class 2 Device Recall Assure 3 Blood Glucose Test Strips

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 Class 2 Device Recall Assure 3 Blood Glucose Test Stripssee related information
Date Initiated by FirmNovember 16, 2007
Date PostedFebruary 01, 2008
Recall Status1 Terminated 3 on October 30, 2008
Recall NumberZ-0699-2008
Recall Event ID 45966
510(K)NumberK002621 K011233 
Product Classification Blood Glucose Test Strips - Product Code CGA
ProductAssure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan.
Code Information Lot Number: AS607L
Recalling Firm/
Manufacturer		 ARKRAY USA INC.
5182 W 76th St
Minneapolis MN 55439-2900
For Additional Information Contact
952-646-3168
Manufacturer Reason
for Recall		Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.
FDA Determined
Cause 2		Process design
ActionOn Friday, November 14, 2007 the recalling firm notified their distributors via telephone and email to inform them of the device defect and replaced all devices still in inventory. The distributors were also instructed to inform all of their customers of the issue and offer replacement product. Additionally, replacement will be offered to any end user that calls customer service about the issue. To reach ARKRAY use 1-800-818-8877 extension 3121 for replacement product.
Quantity in Commerce4,920
DistributionNationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX
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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