Z-0699-2008

Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution...

Name: Z-0699-2008 Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution...
Creator: Arkray USA Inc.
Published: 2007-11-16
License: https://open.fda.gov/license/

Arkray Factory USA, Inc. / initiated 2007-11-16 / Terminated / root cause: manufacturing process

FDA source

ARKRAY USA INC. began a recall of Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard... on 2007-11-16. The reason FDA records is "Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94". 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-0699-2008
Status: Terminated
Initiated: 2007-11-16
Posted: 2008-02-01
Terminated: 2008-10-30
Recalling firm: Arkray Factory USA, Inc.
Product: Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On Friday, November 14, 2007 the recalling firm notified their distributors via telephone and email to inform them of the device defect and replaced all devices still in inventory. The distributors were also instructed to inform all of their customers of the issue and offer replacement product. Additionally, replacement will be offered to any end user that calls customer service about the issue. To reach ARKRAY use 1-800-818-8877 extension 3121 for replacement product.
Quantity in commerce: 4,920
Distribution: Nationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX
Product codes and lots: Lot Number: AS607L

Product code CGA

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)