Events

Recall of Device Recall InflammaDry

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quidel Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77640
  • Event Risk Class
    Class 2
  • Event Number
    Z-2803-2017
  • Event Initiated Date
    2017-06-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157032
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    MMP-9 test system - Product Code PFQ
  • Reason
    In-house testing revealed the presence of plastic spurs at the tips of some sample collectors.
  • Action
    Quidel sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected customers. The notice instructed consignees to check inventory for affected lots (11705359 and 1705405), to remove and destroy any affected sample collectors from affected kits, and complete and return the attached Inventory Assessment/Certificate of Destruction form to Quidel by fax at 858-552-7905 or email to technicalsupport@quidel.com. Any questions by consignees should be directed to Quidel's Technical Support Team at 800-874-1517 or 858-552-1100, or by email at technicalsupport@quidel.com. It is requested that consignees keep recall notification and response in their records.

Device

Device Recall InflammaDry
  • Model / Serial
    Lot numbers: 1705405, 1705359
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Quidel Corporation

Manufacturer

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