Medical device software defect may cause incorrect laboratory test results
A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.
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: This is an FDA Class II medical device recall involving a software defect that may cause erroneous patient laboratory results, representing a risk of harm. No actual illnesses, injuries, or hospitalization reports are mentioned in the source text, placing it at the High threshold rather than Severe.
Plain-English summary
The VITROS XT 7600 Integrated System is a laboratory diagnostic instrument used in clinical settings. Certain units running VITROS Software Version 3.8.1 contain a software defect that prevents quality control baseline statistics from updating correctly when changed by users. This defect may result in erroneous patient laboratory test results being reported.
The recall affects 44 units in the United States and 35 units in other countries. Affected US locations include Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin, and West Virginia. International locations include Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, the United Kingdom, Italy, Spain, Russia, France, and Belgium.
Healthcare facilities operating affected systems should contact Ortho-Clinical Diagnostics for corrective instructions. Affected system serial numbers are listed in the FDA recall notice for device identification.
The recalled product
- Product
- VITROS XT 7600 Integrated System, Catalog No. 6844461
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Distribution
Part of a larger recall action
This product is one of 5 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.
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