Device Recall cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer

  • Model / Serial
    sample probe catalog numbers: 04547241001 - cobas c 501/502 05899427001 - cobas c 311 04945794001 - cobas c 701/702 and cobas 8000 ISE  Lot numbers: cobas c 311 0490232027, 0490233855, 0490236427, 0490238543, 0490241937, 0490248322, 0490250880, 0490235713, 0490252029, 0490256963  cobas c 501, c 502 0490233762, 0490233764, 0490233766, 0490233767, 0490233777, 0490235904, 0490235905, 0490235906, 0490235907, 0490235949, 0490235950, 0490237594, 0490237595, 0490237353, 0490237354, 0490237597, 0490237598, 0490237600, 0490237602, 0490237604, 0490237606, 0490238955, 0490238957, 0490238893, 0490238895, 0490238896, 0490238898, 0490238899, 0490242149, 0490242151, 0490242153, 0490242155, 0490242327, 0490242328, 0490242329, 0490242330, 0490242331, 0490250491, 0490250492, 0490250493, 0490250494, 0490250495, 0490250496, 0490251032, 0490251033, 0490251034, 0490251036, 0490252524, 0490252527, 0490252529, 0490252532, 0490252247, 0490252249, 0490252251, 0490252252, 0490252272, 0490252398, 0490254550, 0490254551, 0490254552, 0490254553, 0490254554, 0490254555, 0490254804, 0490254805, 0490254806, 0490254807, 0490256999, 0490257000, 0490256993, 0490256994, 0490256995, 0490256996, 0490256997, 0490256998, 0490254808, 0490257001, 0490257847, 0490257848, 0490257849, 0490257850, 0490257851, 0490258652  cobas c 701, c 702 0490238960, 0490238961, 0490238963, 0490242332, 0490251040, 0490251041, 0490252546, 0490252547, 0490254810, 0490254811, 0490221658, 0490223228, 0490223229, 0490225255, 0490226172, 0490226173, 0490226174, 0490227626, 0490227627, 0490227628, 0490230276, 0490230277, 0490230279, 0490232203, 0490232204, 0490232205, 0490232206, 0490233778, 0490233779, 0490233780, 0490233781, 0490233783, 0490235909, 0490235910, 0490235911, 0490235912, 0490235913, 0490237365, 0490237366, 0490237367, 0490237368, 0490237369, 0490237370, 0490238901, 0490238902, 0490238903, 0490238904, 0490242160, 0490242161, 0490242163, 0490242165, 0490242166, 0490250498, 0490250499, 0490250500, 0490250501, 0490250502, 0490252308, 0490252312, 0490252318, 0490252320, 0490252322, 0490254558, 0490254559, 0490254560, 0490254561, 0490254562, 0490257035, 0490257036, 0490257037, 0490257038, 0490257039, 0490257854, 0490257855, 0490257856, 0490257857, 0490257858
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide.Distribution
  • Product Description
    Sample probes associated with: || cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer || cobas c 501/502 || cobas c 701/702 || cobas 8000 ISE || Product Usage: || The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source
    USFDA