InflammaDry — Class II medical device recall Z-2803-2017
Terminated recall by Quidel Corporation, reported 2017-08-09, distributed nationwide. In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
| Recall number | Z-2803-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2017-06-22 |
| Classified | 2017-08-01 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2019-06-07 |
| Distributed | Nationwide (US) |
| Lot numbers | 1705359, 1705405 |
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 for recall
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2803-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.