FDA Device recall Z-1129-2013
LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603 by Lifescan, citing 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 prin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1129-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-25 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lifescan |
| Distribution | US |
Product
LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
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.
Identifiers
| code_info | 2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1129-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.