Corrective action/Recall because of a software bug (cobas u 411), Roche
2010.12.15
Product group In-vitro diagnostics
Reference 04455/10
Corrective action/Recall of Roche Diagnostics AG because a software bug has been confirmed for versions 3.1.0.0901 and 3.0.4.0801 so that the instrument (cobas u 411) is transmitting test results to the LIS, even though a T-Flag is present. The customers were informed about the problem and how to avoid it.