Device recall
Z-2201-2020: TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended…
FDA device recall · Class II · Trividia Health, Inc.
Key facts
| Recall number (Z-number) | Z-2201-2020 |
|---|---|
| Recall event | 85535 |
| Product | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. |
| Product code | NBW |
| Recalling firm | Trividia Health, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2021 |
| 510(k) numbers | K150052 |
| FEI number | 1000113657 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database