Abbott Molecular, Inc., FA-AM-MAR2024-298, Alinity m System

The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message "Error - 6013: Has cap, no retention bar." Any color other than black or white within the Keep­Out Zone (See Appendix A) on the tube label can cause the camera to falsely detect a cap, resulting in generation of the error code. Because this is an incorrectly generated error code, the corrective action associated with Message Code: 6013 of "Remove sample rack and add the retention bar with the rack" will not remediate the issue. The correct method to remediate this error code is outlined in the Necessary Actions section of this letter.