Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76854
  • Event Risk Class
    Class 2
  • Event Number
    Z-2049-2017
  • Event Initiated Date
    2017-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154407
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    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.
  • Action
    On March 21, 2017, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Device

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
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Roche Diagnostics Corporation

Manufacturer

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