Ortho's investigation discovered that the self-service customer procedures guide, both onboard and offboard, contains 2 errors related to the probe installation/removal process (chapter 4). 1. The self-service customer procedure guide contains a note indicating the probe can be replaced without using the software maintenance task. If it is performed this way, the instructions do not instruct the operator to condition the probe (daily maintenance) after replacement, which is a required post requisite activity. 2. The self-service customer procedure guide contains a note indicating the software will initiate the pump test, after probe replacement is complete. This is incorrect, since upon completion of the probe replacement maintenance task, the software marks the pipetting volume test as pending rather than the pump test. Note: if the user follows the software's on-screen instructions, daily maintenance is automatically performed during the probe replacement task and the operator is notified of the pending pipetting volume test, which if completed, mitigates this issue. To date, no customer complaints have been recorded regarding this issue. Recall start date: December 21, 2022
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