FDA Device recall Z-2803-2017
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vi…
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vi… by Quidel, citing in-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2803-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-22 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Quidel |
| Distribution | US |
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 diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
Reason
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Identifiers
| code_info | Lot numbers: 1705405, 1705359 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2803-2017%22
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