Device recall
Z-0931-2017: Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE…
FDA device recall · Class III · Sterling Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0931-2017 |
|---|---|
| Recall event | 75591 |
| Product | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. |
| Product code | CGX |
| Recalling firm | Sterling Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 22, 2017 |
| 510(k) numbers | K860418 |
| FEI number | 1831796 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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