Recall Z-0855-2015— Unistrip Technologies LLC

Name: FDA recall Z-0855-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-20

Class II · Terminated

Class II FDA medical device recall by Unistrip Technologies LLC, initiated 2014-11-20, terminated 2015-05-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Failure to submit a 510(k) for device labeling changes..

Recalling firm: Unistrip Technologies LLC
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Terminated: 2015-05-20
Firm location: Charlotte, NC, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.