FDAFDA · Food and drugs·Recall number Z-2803-2017
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.
Published August 9, 2017 · Recall initiated: June 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quidel Corporation
- Distributor
- 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
- Lot numbers: 1705405, 1705359
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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