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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Event Detail

Event ID 67665
Product Type Devices
Status Ongoing
Recalling Firm LumiQuick Diagnostics Inc.
City Santa Clara
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distributed in the states of CA, FL, NJ, TX, and NY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75008, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1416-2014
CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75007, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1415-2014
Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75006, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1414-2014
Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75005, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1413-2014
Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75004, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1412-2014
Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75003, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1411-2014
Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75002, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1410-2014
Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054 Catalog number: 75001, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1409-2014
K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74066, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1408-2014
K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74065, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1407-2014
Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74060, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1406-2014
Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74059, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1405-2014
Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74058, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1404-2014
Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74057, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1403-2014
Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74056, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1402-2014
Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74055, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1401-2014
Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74052, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1400-2014
Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74051, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1399-2014
Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74049, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1398-2014
Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74044, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1397-2014
Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74043, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1396-2014
Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74042, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1395-2014
Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74041 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1394-2014
Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74040 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1393-2014
Ketamine Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74039 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1392-2014
THC Test Card; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74036 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1391-2014
THC Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74035 All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1390-2014
PCP Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74034, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1389-2014
PCP Test (Strip); LumiQuick, Santa Clara, CA 95054 Catalog number: 74033, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1388-2014
Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054 Catalog number: 74032, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1387-2014
Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054 Catalog number: 74031, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1386-2014
Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054 Catalog number: 74030, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1385-2014
Morphine Strip (300); LumiQuick, Santa Clara, CA 95054 Catalog number: 74029, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1384-2014
Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 74028, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1383-2014
Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054 Catalog number: 74027, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1382-2014
Methadone Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74026, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1381-2014
Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054 Catalog number: 74025, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1380-2014
MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74024, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1379-2014
MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74023, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1378-2014
EDDP Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74022, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1377-2014
EDDP Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74021, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1376-2014
Cocaine Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74020, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1375-2014
Cocaine Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74019, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1374-2014
Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74018, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1373-2014
Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74017, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1372-2014
Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74016, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1371-2014
Barbiturate Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74015, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1370-2014
Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74014, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1369-2014
Amphetamine Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74013, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1368-2014
Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054 Catalog number: 74007, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1367-2014
Tramadol Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 74003, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1366-2014
Tramadol Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 74002, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1365-2014
Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054 Catalog number: 74001, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1364-2014
Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054 Catalog number: 72006, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1363-2014
PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054 Catalog number: 72004, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1362-2014
PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054 Catalog number: 72003, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1361-2014
Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 72001, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1360-2014
Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 71087, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1359-2014
Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 71066, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1358-2014
Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054 Catalog number: 71063, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1357-2014
Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054 Catalog number: 71062, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1356-2014
Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054 Catalog number: 71057, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1355-2014
Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054 Catalog number: 71055, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1354-2014
Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054 Catalog number: 71054, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1353-2014
Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054 Catalog number: 71053, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1352-2014
Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054 Catalog number: 71050, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1351-2014
Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71049, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1350-2014
Strep A Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71048, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1349-2014
H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054 Catalog number: 71046, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1348-2014
Legionella Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71034, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1347-2014
Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71033, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1346-2014
Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71032, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1345-2014
Rotavirus Test Card LumiQuick, Santa Clara, CA 95054 Catalog number: 71029, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1344-2014
Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Catalog number: 71028, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1343-2014
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054 Catalog number: 71024, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1342-2014
H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054 Catalog number: 71020, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1341-2014
Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054 Catalog number: 71019, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1340-2014
Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054 Catalog number: 71017, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1339-2014
Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054 Catalog number: 71016, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1338-2014
Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 Catalog number: 71015, All lots Class II Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. ALL Z-1337-2014
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