Z-0276-04

Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10...

Name: Z-0276-04 Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10...
Creator: Hypoguard USA, Inc.
Published: 2003-11-26
License: https://open.fda.gov/license/

Arkray Factory USA, Inc. / initiated 2003-11-26 / Terminated

FDA source

Hypoguard USA, Inc. began a recall of Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips on 2003-11-26. The reason FDA records is "When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0276-04
Status: Terminated
Initiated: 2003-11-26
Posted: 2003-12-25
Terminated: 2005-11-21
Recalling firm: Arkray Factory USA, Inc.
Product: Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
FDA root cause: Other
Action: The consignees were sent letters dated 11/26/03 which requested that the product be returned.
Distribution: The product was distributed to consignees located nationwide in the United States.
Product codes and lots: Lots 01143A, 02263A, 03103A, 10222A, 12212A, 12312A, 03183A, 04293A, and 05273A

Product code CGA

K020232Class IIHypoguard Advance Blood Glucose Monitoring SystemHypoguard USA, Inc. / cleared 2002-02-12

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)