Reported Dec 20, 2023 · Ongoing
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
- Lot codes and dates
- Product Code6844458
- UDI-DI10758750031986
- Serial Numbers
J34500140J34500113J34500180J34500114J34500257J34500116J34500289J34500117J34500319J34500123J34500386J34500128J34500422J34500129J34500447J34500130J34500473J34500139J34500474J34500190J34500510J34500261J34500539J34500269J34500547J34500271J34500579J34500292J34500588J34500301J34500622J34500337J34500656J34500356J34500777J34500363J34500818J34500515J34500887J34500520J34500893J34500536J34500896J34500582J34500911J34500609J34500931J34500628J34500658J34500711J34500793
- Amount recalled
- 51 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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