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 home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monito Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monito
Brand
Oak Tree International Holdings, LLC, Inc.
Lot Codes / Batch Numbers
Lot Number: 222090401, Serial Numbers: 27U000001 - 27U001700, Strip Expiration Date: 2010/09, Lot Number: 222090902: Serial Numbers: 27U001702 - 27U003401, Strip Expiration Date: 2010/11, Lot Number: 222091101, Serial Numbers: 27U003404 - 27U005903, Strip Expiration Date: 2010/11, Lot Number: 222091103, Serial Numbers: 27U008404 - 27U008503, Strip Expiration Date: 2010/11, Lot Number: 222091102, Serial Numbers: 27U005904 - 27U008242, Strip Expiration Date: 2010/11, Lot Number: 222091103, Serial Numbers: 27U008243 - 27U008430, Strip Expiration Date: 2010/11, and Lot Number: 222091201, Serial Numbers: 27U008504 - 27U010503, Strip Expiration Date: 2010/1.
Products Sold
Lot Number: 222090401, Serial Numbers: 27U000001 - 27U001700, Strip Expiration Date: 2010/09; Lot Number: 222090902: Serial Numbers: 27U001702 - 27U003401, Strip Expiration Date: 2010/11; Lot Number: 222091101, Serial Numbers: 27U003404 - 27U005903, Strip Expiration Date: 2010/11; Lot Number: 222091103, Serial Numbers: 27U008404 - 27U008503, Strip Expiration Date: 2010/11; Lot Number: 222091102, Serial Numbers: 27U005904 - 27U008242, Strip Expiration Date: 2010/11; Lot Number: 222091103, Serial Numbers: 27U008243 - 27U008430, Strip Expiration Date: 2010/11; and Lot Number: 222091201, Serial Numbers: 27U008504 - 27U010503, Strip Expiration Date: 2010/1.
Oak Tree International Holdings, LLC, Inc. is recalling EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit cont due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 information, contact EPS Technology Customer Service at 1-866-994-3345.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026