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Terminated

Hypoguard 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)

FDA Recall Z-0458-2008 · Posted 2007-12-13

Recalling FirmARKRAY USA INC.
Recall StatusTerminated
Product CodeCGA
Date Initiated2007-10-18
Date Terminated2008-03-02
Product Quantity2,005 Kits

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

Firm Action

Distributors 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.

Root Cause

Process control

Distribution Pattern

Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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