Devices

Device Recall COBAS

  • Model / Serial
    COBAS TaqMan 48 Analyzer Serial Numbers: 1184; 1077; 1084; 1131; 1135; 1139; 1141; 1143; 1144; 1180; 1185; 1236; 1284; 1453; 1454; 391174; 391171; 1343; 1186; 1052; 1241; 1340; 1045; 1240; 1367; 1402; 1342; 1237; 1244; 1401; 1112; 1175; 1058; 1142; 1039; 1439; 1245; 1111; 1341; 1348; 1057; 1179; 1397; 1246; 1299; 1366; 1339; 1177; 1347; 1113; 1137; 1238; 1242; 1346; 1368; 1298; 1440; 1132; 1147; 1114; 1182; 1398; 1145; 1089; 1183; 1140; 1047; 1133; 1138; 1247; 1396; 1369; 1118; 1181; 1243.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.
  • Product Description
    COBAS TaqMan 48 Analyzers.
  • Manufacturer
    Roche Molecular Systems Inc
  • 1 Event

Manufacturer

Roche Molecular Systems Inc
  • Manufacturer Address
    Roche Molecular Systems Inc, 11 Franklin Ave, Belleville NJ 07109-3501
  • Source
    USFDA

36 devices with a similar name

Learn more about the data here

Device Recall Cobas Homocysteine Enzymatic Assay
  • Model / Serial
    05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA  Lot number 69781101
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.
  • Product Description
    Homocysteine test system - Homocysteine Reagent. || 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA || Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall cobas Liat Analyzer
  • Model / Serial
    Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of :TX and NC.
  • Product Description
    cobas Liat Analyzer, for in vitro diagnostic use.
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall cobas p 512 preanalytical system
  • Model / Serial
    Part numbers:05083435001 and 06268854001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
  • Product Description
    cobas p 512 pre-analytical system || Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall cobas Liat Analyzer
Device Recall cobas Liat Influenza A/B Quality Control Kit
  • Model / Serial
    Lot Numbers: 51222E, 60121H, 60201D, and 60229F
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
  • Product Description
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
  • Manufacturer
    Roche Molecular Systems, Inc.
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