Device Recall InflammaDry

  • Model / Serial
    Lot numbers: 1705405, 1705359
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • Manufacturer Parent Company (2017)
  • Source
    USFDA