VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 Recall
Issued December 20, 2023 · Ortho-Clinical Diagnostics, Inc.
In December 2023, Ortho-Clinical Diagnostics, Inc. recalled the VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ortho-Clinical Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Ortho-Clinical Diagnostics, Inc.
- Category
- Health
- Recall date
- December 20, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide. Global Distribution.
- Recall number
- FDA-Z-0546-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Ortho-Clinical Diagnostics, Inc. has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.