The Recall Desk
ModerateFDA (Devices)·Z-1130-2013·Announced 2013-04-24

LifeScan OneTouch Select Control Solution Recalled for Potential Meter Readings

Lifescan Inc is recalling OneTouch Select Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.

What this means for you

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 rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving functional defects or labeling issues without reported serious harm.

Plain-English summary

Lifescan Inc is recalling 132,301 units of LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. The product is used for testing blood glucose levels. The recall covers lots with expiration dates of 9-30-2014 and 10-31-2014.

The recall was initiated because when OneTouch Ultra and OneTouch Select test strips are tested with the 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 worldwide, including nationwide in the United States (including DC and Puerto Rico) and in Russia and Ukraine. Consumers should stop using the recalled control solution and contact Lifescan Inc for further instructions.

The recalled product

Product
LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Manufacturer
Lifescan Inc
Category
Medical Device — Blood Glucose Monitoring
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 (4)

  • 2AA2101
  • Exp. Date: 9-30-2014
  • 2AA2102
  • Exp. Date: 10-31-2-14

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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 →

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