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U.S. Department of Health and Human Services

Class 3 Device Recall Advance Microdraw Blood Glucose Monitoring System

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 Class 3 Device Recall Advance Microdraw Blood Glucose Monitoring Systemsee related information
Date Initiated by FirmOctober 18, 2007
Date PostedDecember 13, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall NumberZ-0458-2008
Recall Event ID 45483
Product Classification Blood Glucose Monitoring System - Product Code CGA
ProductHypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide)
Code Information Part Number 411100, Lot Number: 09177A
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		Mis-labeled/coded strips : Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter will function properly and give accurat
FDA Determined
Cause 2		Process control
ActionDistributors were sent a letter on 10/18/07 asking that product be quarantined. On 10/26/07, an Urgent Voluntary Medical Device Recall letter was sent asking that they return affected product and contact their customers to the retail level.
Quantity in Commerce2,005 Kits
DistributionNationwide: USA including states of CA, MI, MO, MS, NE, OH 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.
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