Mmp-9 Test System
Clinical Chemistry · 21 CFR 862.1540
A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.
Recent MDR events
3 adverse event reports on file
- DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMAug 1, 2018MalfunctionDexcom, Inc.3004753838-2018-078471
- DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMAug 1, 2018MalfunctionDexcom, Inc.3004753838-2018-078472
- DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORJun 5, 2017MalfunctionDexcom, Inc.3004753838-2017-49188
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Quidel CorporationOpen, ClassifiedApr 24, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Z-1636-2024 · View FDA record ↗ - Quidel CorporationOpen, ClassifiedApr 24, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Z-1637-2024 · View FDA record ↗ - Quidel CorporationTerminatedUnknown
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Z-2803-2017 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
1 clearances for this product code