Recall Z-1937-2009 ยท NBW System, Test, Blood Glucose, Over The Counter
Oak Tree International Holdings, LLC, Inc.
EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at
| Date | Sep 10, 2009 (initiated May 26, 2009) |
| Status | Terminated |
| Reason | Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed. |
| Root cause | Process control |
| Action | EPS Technology issued a certified notification letter to the sole distributor/customer: GEMCO, Coconut Creek, FL dated May 26, 2009. The letter describes the potential preset error and its possible consequences to the user/customer. The letter goes on to inform the distributor that EPS Technology Corp. will be sending out letters to all affected user/customers during a direct mailing. If the error is found, the user/customer can either: 1) have the firm's Customer Service Dept. instruct them as to how to fix the unit, or 2) request that a replacement meter be sent to them. For further in |
| Quantity | 5,396 units |
| Distribution | Nationwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VA, WA, WY and HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083099 | EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 Eps Bio Technology Corp., Jan 16, 2009 |