VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries in the source material. The potential hazard—inaccurate diagnostic results from electrical current shifts—is theoretical. Per the recall severity rubric, when a hazard is theoretical with no reported injuries, the maximum score is 3 (High). This qualifies as a risk-of-harm scenario in critical medical equipment.
Plain-English summary
The VITROS XT 3400 Chemistry System (Version 3.7.2 and below, Product Code 6844458) is a laboratory analyzer used for clinical diagnostic testing. The manufacturer is Ortho-Clinical Diagnostics, Inc., and 506 units are subject to this recall.
During system shutdown, the electrical current supplied to the LED component of the Digital Imaging Reflectometer may shift in either the positive or negative direction. Such a shift in electrical current could result in inaccurate test results being reported by the system.
The affected systems have serial numbers beginning with '3400XXXX' (where XXXX is unique to each unit) and carry the UDI-DI: 10758750031986. These systems have been distributed worldwide, including to the United States and facilities in Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, the Netherlands, and the United Kingdom.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- electrical-current-shift
- inaccurate-test-results
Distribution
Distributed nationwide across the United States.
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