VITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging
Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.
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: FDA Class II recall affecting a diagnostic device with potential to cause patient harm through erroneous test results. No reported illnesses, injuries, or hospitalizations; the hazard is theoretical, placing this in the High severity category per the rubric criterion for risk-of-harm products without currently reported injury.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System, a diagnostic analyzer used in clinical laboratories. The recall affects 91 units in the United States and 94 units distributed internationally to 17 countries.
A software defect in VITROS System Software Versions 3.8.0 and 3.8.1 prevents the Configurable Westgard Rules quality control feature from functioning correctly. When a new control is defined, the system fails to flag or report quality control results that meet the statistical criteria for rejection. This defect may cause the system to accept quality control results that do not meet acceptance criteria.
The potential consequence is that erroneous patient test results may be reported without proper quality control alerts. No injuries, illnesses, or adverse events have been reported related to this defect to date.
The recalled product
- Product
- VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Distribution
Distributed nationwide across the United States.
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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