Recall Z-0699-2008 ยท CGA Glucose Oxidase, Glucose
ARKRAY USA INC.
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.
| Date | Feb 1, 2008 (initiated Nov 16, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 4,920 |
| Distribution | Nationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX |
| FDA record | Open on fda.gov |