Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Recalled by Ortho-Clinical Diagnostics, Inc. Due to During planned monitoring of data post-release of Software...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics, Inc. directly.
Affected Products
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Quantity: 216 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report