Quidel Corporation: Medical Device Recall in 2017 - (Recall #: Z-2803-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 22, 2017

Date Posted: August 9, 2017

Recall Number: Z-2803-2017

Event ID: 77640

Reason for Recall:

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

Status: Terminated

Product Quantity: 1078 kits, 21,560 sample collectors

Code Information:

Lot numbers: 1705405, 1705359

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated