Recall Z-0458-2008 ยท CGA Glucose Oxidase, Glucose
ARKRAY USA INC.
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 Guid
| Date | Dec 13, 2007 (initiated Oct 18, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process control |
| 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. |
| Quantity | 2,005 Kits |
| Distribution | Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.