Recall Z-2027-2010
Lifescan Inc · initiated February 24, 2010
Product
OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 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 home settings (SureStep).
Codes / lots: Part Number 02005201 (100 count), lot numbers 2969798, 2969251, 2982369, 2983467; Part number 01035904 (50 count), lot numbers 2969795 and 2982566; Part number 02096401 (50 count mail order pack), lot numbers 2969481 and 2998193
Reason for recall
Products may provide inaccurate results at readings over 400 mg/dL
FDA-determined cause: Other
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.
Details
- Recall number
- Z-2027-2010
- Initiated
- February 24, 2010
- Posted by FDA
- July 17, 2010
- Terminated
- December 8, 2010
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 1,014,350
- Distribution
- Worldwide distribution: USA and countries of Europe, Latin America and Asia.
- Recalling firm
- Lifescan Inc, Milpitas, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2028-2010 | OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose…Products may provide inaccurate results at readings over 400 mg/dL | 02/24/2010Terminated |