VITROS XT7600 System Aspiration Risk During Sample Processing
Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 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 an FDA Class II medical device recall involving potential aspiration of sample containers during processing, which may lead to erroneous test results. No illnesses or injuries are reported in the source material, and the hazard is described as potential rather than confirmed, placing this in the High severity category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS XT7600 Integrated System, a clinical diagnostic testing device used in laboratory settings. The recall affects 1,720 units distributed worldwide, including 834 units in the United States and 886 units internationally. The affected serial numbers range from J76000109 through J76001913 (inclusive).
During sampling center processing, there is a potential for aspiration of an unintended sample container. This condition may result in erroneous test results, compromising the reliability of clinical diagnostic information.
The product is distributed to healthcare facilities and diagnostic laboratories internationally, including throughout the United States, Canada, Australia, Brazil, Japan, and other countries worldwide.
The recalled product
- Product
- VITROS XT7600 Integrated System
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- aspiration
- erroneous-test-results
- equipment-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Code Information: UDI/DI: 10758750031610
- Serial Numbers: J76000109 through J76001913 (inclusive).
Distribution
Distributed nationwide across the United States.
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