Z-0855-2015Class II

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

Name: Z-0855-2015 UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with...
Creator: Unistrip Technologies LLC
Published: 2014-11-20
License: https://open.fda.gov/license/

Unistrip Technologies LLC / initiated 2014-11-20 / Terminated / root cause: labeling and UDI

FDA source

Unistrip Technologies LLC began a recall of 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... on 2014-11-20. FDA classified it as Class II and gives the reason as "Failure to submit a 510(k) for device labeling changes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0855-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Posted: 2014-12-23
Terminated: 2015-05-20
Recalling firm: Unistrip Technologies LLC
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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Failure to submit a 510(k) for device labeling changes.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.
Quantity in commerce: 7175 units
Distribution: US Distribution to the states of FL and OH.
Product codes and lots: U14030713, 814031313, U140312323, and U14031413.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0855-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0855-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code NBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)