Z-0458-2008

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

Name: Z-0458-2008 Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro...
Creator: Arkray USA Inc.
Published: 2007-10-18
License: https://open.fda.gov/license/

Arkray Factory USA, Inc. / initiated 2007-10-18 / Terminated / root cause: manufacturing process

FDA source

ARKRAY USA INC. began a recall of Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc... on 2007-10-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0458-2008
Status: Terminated
Initiated: 2007-10-18
Posted: 2007-12-13
Terminated: 2008-03-02
Recalling firm: Arkray Factory USA, Inc.
Product: 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)
Product code: CGA Glucose Oxidase, Glucose
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
Root cause tag: manufacturing process
FDA 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 in commerce: 2,005 Kits
Distribution: Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.
Product codes and lots: Part Number 411100, Lot Number: 09177A

Product code CGA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)