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)
Recall
- Recall Number
- Z-0458-2008
- Event Number
- 45483
- Firm
- ARKRAY USA INC.
- FEI Number
- 1832816
- Product Code
- CGA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 18, 2007
- Posted
- December 13, 2007
- Terminated
- March 2, 2008
- Address
- 5182 W 76th St, Minneapolis, MN, 55439-2900
Description
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)
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
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.
Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.
2,005 Kits