510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,528 records, page 714 of 1191
FDA device recalls, page 714 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1389-2014Class IIPCP Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1388-2014Class IIPCP Test (Strip); LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1387-2014Class IIMorphine Test Card (2000); LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1386-2014Class IIMorphine Strips (2000); LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1385-2014Class IIMorphine Test Card (300); LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1384-2014Class IIMorphine Strip (300); LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1383-2014Class IIMethamphetamine Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1382-2014Class IIMethamphetamine Strip; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1381-2014Class IIMethadone Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1380-2014Class IIMethadone Test Strip; LumiQuick,. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1379-2014Class IIMDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1378-2014Class IIMDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1377-2014Class IIEDDP Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1376-2014Class IIEDDP Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1375-2014Class IICocaine Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1374-2014Class IICocaine Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1373-2014Class IIBenzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1372-2014Class IIBenzodiazepine Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1371-2014Class IIBarbiturate Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1370-2014Class IIBarbiturate Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1369-2014Class IIAmphetamine Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1368-2014Class IIAmphetamine Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1367-2014Class IIDrugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1366-2014Class IITramadol Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1365-2014Class IITramadol Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1364-2014Class IIAlcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1363-2014Class IIFecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1362-2014Class IIPSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1361-2014Class IIPSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1360-2014Class IIFecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1359-2014Class IIDengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1358-2014Class IIDengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1357-2014Class IIMalaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1356-2014Class IITuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1355-2014Class IISyphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1354-2014Class IISalmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1353-2014Class IISalmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1352-2014Class IIMalaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1351-2014Class IIMalaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1350-2014Class IIMalaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1349-2014Class IIStrep A Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1348-2014Class IIH. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1347-2014Class IILegionella Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1346-2014Class IIAdeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1345-2014Class IIAdenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1344-2014Class IIRotavirus Test Card LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1343-2014Class IISalmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1342-2014Class IIH. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1341-2014Class IIH. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.
Z-1340-2014Class IIDengue IgG/IgM; LumiQuick, Santa Clara, CA 95054LumiQuick Diagnostics Inc.