Recall Z-2028-2010 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary
| Date | Jul 17, 2010 (initiated Feb 24, 2010) |
| Status | Terminated |
| Reason | Products may provide inaccurate results at readings over 400 mg/dL |
| Root cause | Other |
| Action | The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immedi |
| Quantity | 8,626,350 |
| Distribution | Worldwide distribution: USA and countries of Europe, Latin America and Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM Lifescan, Inc., Oct 24, 2002 |