LifeScan OneTouch Ultra Control Solution Recalled for Potential Meter Readings
LifeScan Inc is recalling OneTouch Ultra Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential inaccurate meter readings due to control solution performance, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for minor labeling or functional errors without reported serious harm.
Plain-English summary
LifeScan Inc is recalling 132,301 units of LifeScan brand OneTouch Ultra Control Solution, Part Numbers 01045808 and 02141603. The product is used for testing blood glucose levels. The recall covers specific lot codes with expiration dates ranging from July 31, 2014, to December 31, 2014.
The recall was initiated because when OneTouch Ultra and OneTouch Select test strips are tested with the affected Ultra and Select control solution, the meter may display a result outside the control solution test range printed on the strip vial label. This can occur even though the system is working properly.
The affected products were distributed nationwide in the United States, including DC and Puerto Rico, as well as in Russia and Ukraine. Consumers should stop using the recalled control solution and contact LifeScan Inc for further instructions or a replacement.
The recalled product
- Product
- LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
- Manufacturer
- Lifescan Inc
- Hazard
- Affected units
- 132,301
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 2AA2G01
- Exp. Date: 7-31-2014
- 2AA2G02
- 2AA2G03
- Exp. Date: 8-31-2014
- 3AA2G04
- Exp. Date: 12-31-2014
- 3AA2G05
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lifescan Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Lifescan Inc
See all →- ModerateLifeScan OneTouch Select Control Solution Recalled for Potential Meter Readings
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