Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manu

FDA device recall Z-0458-2008 · posted 2007-12-13 · Terminated

Recall details

Recalling firm

ARKRAY USA INC.

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

Action taken

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

Status

Terminated

Product code

CGA

Quantity affected

2,005 Kits

Distribution

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

Date initiated

2007-10-18

Date posted

2007-12-13

Date terminated

2008-03-02

Location

Minneapolis, MN