Device 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.
Z-2803-2017
Product summary
- Event
- Event 77640
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1078 kits, 21,560 sample collectors
- Official record key
device-enforcement:Z-2803-2017
Official wording
Reason: In-house testing revealed the presence of plastic spurs at the tips of some 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.
Derived failure modes
-
Unknown
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.