Recall Z-2803-2017— Quidel Corporation

Name: FDA recall Z-2803-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-22

Class II · Terminated

Class II FDA medical device recall by Quidel Corporation, initiated 2017-06-22, terminated 2019-06-07. It names one FDA 510(k) clearance: K132066. 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..

Recalling firm: Quidel Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-06-22
Terminated: 2019-06-07
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132066 — INFLAMMA DRYRapid Pathogen Screening, Inc.·cleared 2013-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.