Device recall
Z-2803-2017: InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a…
FDA device recall · Class II · Quidel Corporation
Key facts
| Recall number (Z-number) | Z-2803-2017 |
|---|---|
| Recall event | 77640 |
| Product | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the… |
| Product code | PFQ |
| Recalling firm | Quidel Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2019 |
| 510(k) numbers | K132066 |
| FEI number | 2024674 |
At a glance
- 1–9 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