Roche Diagnostics Corporation: Medical Device Recall in 2017 - (Recall #: Z-2049-2017)

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.

Class II

Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.

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

US Nationwide.Distribution

Voluntary: Firm initiated