Ortho VITROS 5600 System Recall for Software Parameter Reset Issue
Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems because software modifications to assay parameters may be inadvertently reset to default.
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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software defect that may lead to parameter resets, which is a moderate risk without confirmed adverse health events.
Plain-English summary
Ortho Clinical Diagnostics is recalling 130 refurbished VITROS 5600 Integrated Systems (Product Code: 6802915) equipped with software versions 3.3.3 and below. The recall involves 57 units in the United States and 73 units in foreign countries, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, France, Indonesia, India, Japan, South Korea, Mexico, Malaysia, Nepal, Peru, Philippines, Singapore, Thailand, Trinidad and Tobago, Venezuela, and Vietnam.
The recall is issued because modifications to MicroWell Qualitative Assay Parameters are not retained and may be inadvertently reset to default in certain circumstances. This issue could affect the accuracy of test results if parameters are not manually re-verified.
Healthcare facilities and laboratories should check their inventory for the specific serial numbers listed in the recall notice. Affected units should be identified and reported to Ortho Clinical Diagnostics for further instructions on remediation or replacement.
The recalled product
- Product
- VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
- Manufacturer
- Ortho Clinical Diagnostics
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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