Reported Apr 24, 2013 · Terminated

LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood…

Lifescan Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lifescan Inc · 1000 Gibraltar Dr · Milpitas, CA · 95035-6301

Is this the product you have?

  • LifeScan brand OneTouch¿ Ultra Control Solution
  • Part Numbers/Model Numbers
    • 01045808
    • 02141603. Testing of Blood Glucose Levels
Lot codes and dates
  • 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
  • Date12-31-2014
Amount recalled
132,301 units total

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 23, 2013 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.