Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 12/13/2023
Class II
PRODUCT
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Recall Number:
Z-0543-2024
REASON:
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
RECALLING FIRM/MANUFACTURER:
Ortho-Clinical Diagnostics, Inc.
VOLUME OF PRODUCT IN COMMERCE:
63 units
DISTRIBUTION:
US Nationwide. Global Distribution.
