13

Dec

2023

FDA Recall: Software Issues Causing Delays in Reporting Results

0

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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