Laboratory diagnostic system may report inaccurate results during shutdown
The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential for inaccurate test results from electrical shifts during system shutdown—placing it in the High severity category per the rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
The VITROS XT 7600 Integrated System, manufactured by Ortho-Clinical Diagnostics, Inc., is subject to a Class II recall. When the system performs a shutdown, the electrical current supplied to the LED component used in the Digital Imaging Reflectometer may shift, potentially causing positive or negative shifts in the reported test results.
Approximately 1,148 units have been distributed worldwide, including throughout the United States and in numerous countries. The affected product includes systems with Version 3.7.2 and below, identified by Product Code 6844461 and UDI-DI code 10758750031610.
The recalled product
- Product
- VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 1,148
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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