Roche Modular Operator Manual
Roche is celebrating an important milestone - 5000 installations of the cobas® 8000 modular analyzer series 1. In 2017 alone, an estimated 5.6 billion tests were performed on the cobas 8000 worldwide 2. 2nd Generation SWA: modular, analytical system platform, consolidated work area for. Routine, STAT, Control, Calibrator, Rerun (manual), Wash.
Recalls and Alerts Medical Device Safety Alert: Roche Diagnostics cobas 8000 Operator’s Manual version 5.0 Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its cobas 8000 modular operator’s Manual version 5.0. The systems affected are cobas e 602 module (catalogue number 1) and cobas e 801 module (catalogue number 1).
Roche Modular Operators Manual
The manufacturer is informing customers that they found discrepant information between the previous versions 4.2.1 and 5.0 cobas 8000 operator’s manuals (OM) for non-standard tubes (NSTs). The version 5.0 OM incorrectly states that 11 to 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. However, only NST diameters of 13 to 16 mm are permitted on these modules. Only the version 5.0 cobas 8000 OM was incorrect for minimum NST diameter on the cobas e 602 and cobas e 801 modules. All previous OM versions correctly specified a 13 to 16 mm NST diameter for tile cobas e 602 module.
According to the manufacturer, if a sample tube with a too narrow diameter (.