VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Summary
The FDA issued a Class II for VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3. by Ortho-Clinical Diagnostics, Inc.. Reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystem.
Details
Source
Device Recall
External ID
Z-0546-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Lot/Code Info: Product Code: 6844458, UDI-DI: 10758750031986; Serial Numbers: J34500140 J34500113 J34500180 J34500114 J34500257 J34500116 J34500289 J34500117 J34500319 J34500123 J34500386 J34500128 J34500422 J34500129 J34500447 J34500130 J34500473 J34500139 J34500474 J34500190 J34500510 J34500261 J34500539 J34500269 J34500547 J34500271 J34500579 J34500292 J34500588 J34500301 J34500622 J34500337 J34500656 J34500356 J34500777 J34500363 J34500818 J34500515 J34500887 J34500520 J34500893 J34500536 J34500896 J34500582 J34500911 J34500609 J34500931 J34500628 J34500658 J34500711 J34500793
Quantity Affected: 51 units
Reason for Recall
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.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-10
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0546-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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