Incomplete records for all blood components produced; failure to routinely review error messages on computer system. The inspection also revealed that _____ error messages on your computer system are not routinely reviewed, processed, and investigated to determine final disposition. The instructions for computer system training do not include a clear written explanation of what error...Read More

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...Read More