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Quidel Corporation recalls InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual
Recalled August 9, 2017 · FDA recall Z-2803-2017 · Quidel
Hazard
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. · FDA Class II
Units
1078 kits, 21,560 sample collectors
Sold at
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.
Description
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
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.
Manufacturer(s)
Quidel Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →