Device recall
Z-1128-2021: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for…
FDA device recall · Class II · Cairn Diagnostics
Key facts
| Recall number (Z-number) | Z-1128-2021 |
|---|---|
| Recall event | 87186 |
| Product | 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis. |
| Product code | PGE |
| Recalling firm | Cairn Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2023 |
| FEI number | 3009091796 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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