Ortho VITROS XT 7600 Software Recall for Parameter Reset Issue
Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves a software parameter reset that may affect test accuracy rather than causing direct physical injury or death. No illnesses or injuries are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System Software Versions 3.5.1 and below. The recall involves 353 units, with 167 distributed in the United States and 186 distributed internationally. The affected serial number range is J76000111-J76000525.
The recall is due to a software defect where modifications to MicroWell Qualitative Assay parameters are not retained and may be inadvertently reset to default settings in certain circumstances. This issue could affect the accuracy of test results if parameters are not manually verified.
Healthcare facilities and laboratories using the affected software versions should contact Ortho Clinical Diagnostics for instructions on how to resolve the issue. Users should verify that their assay parameters are correctly set before running tests.
The recalled product
- Product
- VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
- Manufacturer
- Ortho Clinical Diagnostics
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 (1)
- Affected Serial Number Range: J76000111-J76000525
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Ortho Clinical Diagnostics 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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