Devices

Roche cobas e 602 module

  • Modèle / numéro de série
    Part Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution
  • Description du dispositif
    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. || Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

Fabricant

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA

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Device Recall Roche cobas e 602 module
  • Modèle / numéro de série
    1125-07,1017-06,1021-03,1021-05,1016-05,1017-01,1124-05,1124-06,1128-02,1132-03,1132-04,1131-08,1132-01,1132-02,1128-05,1128-06,2374-11,1132-05,1132-10,1137-02,1139-08,1139-10,1140-07,1140-10,1140-08,1146-01,1146-02,1146-03,1139-06,1139-07,1139-09,1142-09,1145-10,1138-10,1139-01,1127-08,1138-08,1146-05,1146-06,1147-04,1156-04,1140-01,1147-05,1149-01,1149-07,1149-08,1167-02,1156-06,1158-09,1156-05,1158-10,1139-02,1139-03,1139-04,1139-05,1160-01,1160-05,1171-07,1171-08,1171-09,1173-10,1156-01,1160-04,1156-07,1156-02,1156-09,1160-06,1171-10,1173-01,1169-06,1169-08,1169-09,1172-09,1182-08,1211-15,1211-14,1174-08,1160-08,1171-06,1174-06,1174-07,1211-13,1211-06,1183-04,1217-09,1225-11,1211-16,1211-17,1211-18,1224-10,1156-08,1156-10,1225-14,1331-13,1338-15,1338-16,1211-19,1211-04,1211-05,1211-20,1208-08,1208-09,1211-02,1211-03,1338-12,1338-13,1338-14,1208-05,1211-07,1211-08,1458-04,1331-10,1331-11,1331-12,1334-15,1335-13,1344-02,1344-03,1344-04,1344-05,1344-06,1357-07,1357-08,1357-09,1357-10,1357-19,1357-20,1334-12,1334-13,1334-14,1459-12,1459-13,1357-15,1357-16,1357-17,1357-18,1335-08,1335-09,1335-10,1335-11,1344-01,1344-07,1344-08,1461-01,1461-02,1344-09,1459-14,1459-10,1459-11,, ,
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    cobas 8000 analyzer series Operators Manual Roche cobas || Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) || Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
  • Manufacturer
    Roche Diagnostics Operations, Inc.