4/30/99 Bayer Diagnostics 1000 units. Class II ADVIA 120 Hematology System When running the ADVIA 120 system in the manual mode using the Host Query feature and the timeout is set to 13 seconds, it is possible for the system to report incorrect patient results. The supplemental labeling instructions section of the product labeling instructs users to verify that the correct sample identification number appears on the status line before using either of the manual samplers. However, the user is not clearly told to review the supplemental operating instructions prior to the operation of the system. Z-1073/1074-9
