# FDA recall Z-2803-2017

> **Quidel Corporation** · Class II · device recall initiated 2017-06-22.

## 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.

## Distribution

Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.

## Key facts

- **Recall number:** Z-2803-2017
- **Recalling firm:** Quidel Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-22
- **Report date:** 2017-08-09
- **Termination date:** 2019-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2803-2017

## Citation

> AI Analytics. FDA recall Z-2803-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2803-2017. Source: US FDA. Licensed CC0.

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