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.
FDA Recall Z-2803-2017 · Posted None
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Recalling FirmQuidel Corporation
Recall StatusTerminated
Product CodePFQ
Date Initiated2017-06-22
Date Terminated2019-06-07
Product Quantity1078 kits, 21,560 sample collectors
Reason for Recall
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Firm 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 [email protected]. 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 [email protected]. It is requested that consignees keep recall notification and response in their records.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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