Class II — Lifescan Inc
| Recalling firm | LifeScan U.S. LLC |
|---|---|
| Registered facility | LifeScan U.S. LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | LifeScan brand OneTouch® Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels. |
| Quantity | 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine. |
| Initiated | 2013-02-25 |
| Classified | 2013-04-17 |
| Terminated | 2013-10-23 |
| Recall number | Z-1130-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lifescan Inc (Z-1130-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64478/
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