FDA Medical Device Recalls (openFDA)
Quidel Corporation: 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 number
- Z-2803-2017
- Recalling firm
- Quidel Corporation
- 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.
- Status
- Terminated
- Initiated
- 2017-06-22
- Posted
- not on file
- Terminated
- 2019-06-07
- Reason
- In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
- Root cause
- Process design
- 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.
- Quantity
- 1078 kits, 21,560 sample collectors
- 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.
- Lot, serial or model codes
- Lot numbers: 1705405, 1705359
- 510(k) numbers
- ["K132066"]
- PMA numbers
- not on file
- Product code
- PFQ
- Firm FEI
- 2024674
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28