LifeScan brand OneTouch¿ Ultra Control Solution — Class II medical device recall Z-1129-2013
Terminated recall by Lifescan Inc, reported 2013-04-24, distributed nationwide. When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the me
| Recall number | Z-1129-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lifescan Inc, Milpitas, CA, United States |
| Recall initiated | 2013-02-25 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | RU, UA |
| Quantity | 132,301 units |
| Reason classes | labeling |
| Model numbers | 01045808, 02141603 |
| Expiration dates | 2014-07-31, 2014-08-31, 2014-12-31 |
Product
LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1129-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.