Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION Recalled by Quidel Corporation Due to In-house testing revealed the presence of plastic spurs...

Date: June 22, 2017
Company: Quidel Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Quidel Corporation directly.

Affected Products

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.

Quantity: 1078 kits, 21,560 sample collectors

Why Was This Recalled?

In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Quidel Corporation

Quidel Corporation has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report