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.
FDA Recall Z-0699-2008 · Posted 2008-02-01
Recalling FirmARKRAY USA INC.
Recall StatusTerminated
Product CodeCGA
Date Initiated2007-11-16
Date Terminated2008-10-30
Product Quantity4,920
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
Nationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.