Ortho VITROS 3600 Software Recall for Parameter Reset Issue
Ortho Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System software versions 3.3.3 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, and the hazard involves a software defect that may lead to inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System Software, versions 3.3.3 and below. The recall involves 779 units, with 225 units distributed in the United States and 554 units distributed internationally. The affected serial number range is J36000109-J36001317.
The recall was initiated because 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 diagnostic results.
Healthcare facilities and users of the VITROS 3600 system should check their software versions and serial numbers. If the equipment is affected, users should contact Ortho Clinical Diagnostics for instructions on how to resolve the issue.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
- 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: J36000109-J36001317
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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