Reported Aug 9, 2017 · Terminated
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the…
Quidel Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quidel Corporation · 10165 McKellar Ct · San Diego, CA · 92121-4201
Is this the product you have?
- 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.
- Lot codes and dates
- Lot numbers
17054051705359
- Lot numbers
- Amount recalled
- 1078 kits, 21,560 sample collectors
Where it was sold
Why it was recalled
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
This product could cause temporary or reversible health problems — stop using it.
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