Ortho VITROS 3600 System Recalled for Assay Parameter Reset Issue
Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems because assay parameters may reset to defaults, potentially affecting test 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 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 functional defect (parameter reset) that may affect test accuracy, fitting the criteria for a moderate severity recall without reported adverse health consequences.
Plain-English summary
Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems (Product Code 6802914). 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.
The affected units were distributed nationwide in the United States and in 23 foreign countries, including Argentina, Australia, Brazil, Canada, and China. The recall covers specific serial numbers, including 36000192, 36000396, and 36000430, among others.
Healthcare facilities and laboratories should check their inventory for the affected serial numbers. Users should contact Ortho Clinical Diagnostics for instructions on how to address the parameter retention issue to ensure accurate diagnostic results.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
- 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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