LumiQuick Diagnostics Inc.
FDA Regulatory Profile
LumiQuick Diagnostics Inc. appears in FDA public data with 80 recalls, 1 510(k) clearance, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1371-2014, Class II) was initiated on March 4, 2014. Its most recent 510(k) clearance was granted on October 18, 2013.
Summary
- Total Recalls
- 80
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1371-2014 | Class II | Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1390-2014 | Class II | THC Strip; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1373-2014 | Class II | Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1379-2014 | Class II | MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1359-2014 | Class II | Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1343-2014 | Class II | Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054 | March 4, 2014 |
| Z-1391-2014 | Class II | THC Test Card; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1344-2014 | Class II | Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 | March 4, 2014 |
| Z-1377-2014 | Class II | EDDP Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1396-2014 | Class II | Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1378-2014 | Class II | MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1405-2014 | Class II | Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1398-2014 | Class II | Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1383-2014 | Class II | Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054 | March 4, 2014 |
| Z-1394-2014 | Class II | Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1403-2014 | Class II | Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1358-2014 | Class II | Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1412-2014 | Class II | Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1381-2014 | Class II | Methadone Test Card; LumiQuick. Santa Clara, CA 95054 | March 4, 2014 |
| Z-1385-2014 | Class II | Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054 | March 4, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130213 | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE | October 18, 2013 |