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Unistrip Technologies LLC recalls UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in
Recalled December 31, 2014 · FDA recall Z-0855-2015 · Unistrip Technologies
Hazard
Failure to submit a 510(k) for device labeling changes. · FDA Class II
Units
7175 units
Sold at
US Distribution to the states of FL and OH.
Description
Failure to submit a 510(k) for device labeling changes.
Product
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.
Manufacturer(s)
Unistrip Technologies LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →