Recall Z-2803-2017
Quidel Corporation · initiated June 22, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot numbers: 1705405, 1705359
Reason for recall
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-2803-2017
- Initiated
- June 22, 2017
- Terminated
- June 7, 2019
- Product code
- PFQ – Mmp-9 Test System
- 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.
- Recalling firm
- Quidel Corporation, San Diego, CA