Recall Z-2803-2017 ยท PFQ Mmp-9 Test System
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 p
| Date | Jun 22, 2017 |
| Status | Terminated |
| 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 requ |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132066 | INFLAMMA DRY Rapid Pathogen Screening, Inc., Nov 21, 2013 |