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UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by p...

FDA Recall #Z-0855-2015 — Class II — November 20, 2014

Recall #Z-0855-2015 Date: November 20, 2014 Classification: Class II Status: Terminated

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.

Recalling Firm

Unistrip Technologies LLC — Charlotte, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7175 units

Distribution

US Distribution to the states of FL and OH.

Code Information

U14030713, 814031313, U140312323, and U14031413.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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