BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2803-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2803-2017
    Event ID
    77640
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    June 22, 2017
    Classification Date
    August 1, 2017
    Termination Date
    June 7, 2019
    Address
    10165 McKellar Ct, N/A, San Diego, CA, 92121-4201, United States

    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

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

    Code Info

    Lot numbers: 1705405, 1705359

    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.

    Quantity

    1078 kits, 21,560 sample collectors