Unistrip Technologies LLC: Medical Device Recall in 2014 - (Recall #: Z-0855-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 20, 2014

Date Posted: December 31, 2014

Recall Number: Z-0855-2015

Event ID: 69856

Reason for Recall:

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

Status: Terminated

Product Quantity: 7175 units

Code Information:

U14030713, 814031313, U140312323, and U14031413.

Distribution Pattern:

US Distribution to the states of FL and OH.

Voluntary or Mandated:

Voluntary: Firm initiated