Z-1410-2014Class II
Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc. / initiated 2014-03-04 / Terminated
LumiQuick Diagnostics Inc. began a recall of Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 on . FDA classified it as Class II and gives the reason as "Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1410-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- LumiQuick Diagnostics Inc.
- Product
- Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
- Reason for recall
- Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
- FDA root cause
- No Marketing Application
- Action
- Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
- Quantity in commerce
- ALL
- Distribution
- Distributed in the states of CA, FL, NJ, TX, and NY.
- Product codes and lots
- Catalog number: 75002, All lots
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1337-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1338-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1339-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1340-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1341-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1342-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1343-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1344-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1345-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1346-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1347-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1348-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1349-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1350-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1351-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1352-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1353-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1354-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1355-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1356-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1357-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1358-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1359-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1360-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1361-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1362-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1363-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1364-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1365-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1366-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1367-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1368-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1369-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1370-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1371-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1372-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1373-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1374-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1375-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1376-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1377-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1378-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1379-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1380-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1381-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1382-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1383-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1384-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1385-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1386-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1387-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1388-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1389-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1390-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1391-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1392-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1393-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1394-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1395-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1396-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1397-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1398-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1399-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1400-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1401-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1402-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1403-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1404-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1405-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1406-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1407-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1408-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1409-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1410-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1411-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1412-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1413-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1414-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1415-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1416-2014 | Class II | Terminated | Voluntary: Firm initiated |
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