OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging di
FDA device recall Z-2028-2010 · posted 2010-07-17 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Products may provide inaccurate results at readings over 400 mg/dL
- Action taken
- 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 immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 8,626,350
- Distribution
- Worldwide distribution: USA and countries of Europe, Latin America and Asia.
- Date initiated
- 2010-02-24
- Date posted
- 2010-07-17
- Date terminated
- 2010-12-08
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM (K023194) | Lifescan, Inc. | 2002-10-24 |