Z-2803-2017 Class II Terminated
FDA device recall Z-2803-2017 was initiated by Quidel Corporation on June 22, 2017 and is designated Class II. Reason for recall: In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. The recall status is terminated (terminated June 7, 2019). Affected quantity: 1078 kits, 21,560 sample collectors.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- June 22, 2017
- Termination Date
- June 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1078 kits, 21,560 sample collectors
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.
Reason for Recall
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
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.
Code Information
Lot numbers: 1705405, 1705359