Class II — Unistrip Technologies LLC
| Recalling firm | UniStrip Technologies, LLC |
|---|---|
| Registered facility | UNISTRIP TECHNOLOGIES, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Failure to submit a 510(k) for device labeling changes. |
| 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. |
| Quantity | 7175 units |
| Distribution | US Distribution to the states of FL and OH. |
| Initiated | 2014-11-20 |
| Classified | 2014-12-23 |
| Terminated | 2015-05-20 |
| Recall number | Z-0855-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Unistrip Technologies LLC (Z-0855-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69856/
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