Roche cobas b 123 User Manual

Roche Diagnostics
Instructions for Use · Version 13.0 235
cobas b 123 POC system 9 Calibration verification control
General information
General information
Calibration verification is used to test your instrument’s accuracy. Materials of
known concentration are used to assure that the instrument is accurately measuring
values throughout its measuring ranges.
This CVC has to be performed to fulfill CLIA-88 regulations at 42CFR493.1255(b)(3)
at least once every 6 months, or more often if:
o Fluid Pack and/or Sensor Cartridge lot numbers are changed, unless the
laboratory can demonstrate that changing reagent lot numbers does not affect the
ranges used to report patient test results, and control values are not adversely
affected by reagent lot number changes,
o There is major preventive maintenance or a replacement of critical parts that may
influence the instrument’s performance,
o After depot repair, or
o Control materials reflect an unusual trend or shift, or are outside of the specified
ranges.

Roche cobas b 123 Specifications

General

Brand	Roche
Model	cobas b 123
Category	Medical Equipment
Language	English