FDA Device recall Z-0855-2015
UniStrip1, Blood Glucose Test Strips, 50 count box
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of UniStrip1, Blood Glucose Test Strips, 50 count box by Unistrip Technologies, citing failure to submit a 510(k) for device labeling changes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0855-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-20 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Unistrip Technologies |
| Distribution | FL, OH |
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.
Identifiers
| code_info | U14030713, 814031313, U140312323, and U14031413. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0855-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.