Cobas b 123 POC system 의 리콜

Recall

75709

Class 2

Z-1077-2017

2015-09-03

2017-01-23

Terminated

United States

2017-06-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151082

Under specific settings, an issue may occur during simultaneous sensor cartridge and fluid pack change on the cobas b 123 <2> poc system and cobas b 123 <4> poc system. the issue occurs when the software function [autoqc as follow-up] is configured to run all three levels of autoqc only after a fluid pack change, but not after a sensor cartridge change. when both are changed simultaneously, starting with the sensor cartridge and followed by the fluid pack, the analyzer carries out only the follow-up actions associated with the sensor cartridge change after completing the change workflow. as a result, no follow-up autoqc is performed and the three expected autoqc measurements for the fluid pack change are not carried out. without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: ph, po2, pco2, na+, k+, ca++, cl-, glu, lac, hct, so2, o2hb, cohb, methb, hhb, and bili.

Roche issued an Analyzer Bulletin on September 3, 2015, to all affected Consignees. The recall notifications included a description of the reason for the recall, affected product, and consignee responsibilities; the notification did not include instructions for responding to the notification. Actions Required " Follow the workaround outlined in this Analyzer Bulletin to avoid the described issue. " File this Analyzer Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions about the information contained in this Analyzer Bulletin.