LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
FDA device recall Z-1130-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
- Action taken
- LifeScan sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers may contact OneTouch Healthcare Professional Line at 866-461-0089 for questions about this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 132,301 units total
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, N
- Date initiated
- 2013-02-25
- Date posted
- 2013-04-17
- Date terminated
- 2013-10-23
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM (K072543) | Lifescan, Inc. | 2007-10-05 |