Reported Dec 31, 2014 · Terminated

UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in…

Unistrip Technologies LLC

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: Unistrip Technologies LLC · 301 Mccullough Dr · Charlotte, NC · 28262-3310

Is this the product you have?

  • UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Lot codes and dates
    • U14030713
    • 814031313
    • U140312323
    • and U14031413
Amount recalled
7175 units

Where it was sold

Why it was recalled

Failure to submit a 510(k) for device labeling changes.

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 May 20, 2015 · Data as of Sep 19, 4:46 PM UTC

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