Laboratory chemistry system software defect impairs quality control reporting
A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being 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: This is an FDA Class II device recall with no reported hospitalizations, illnesses, injuries, or deaths. The software defect presents a risk-of-harm situation where patient result errors could occur if quality control checks fail to function properly, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems with software versions 3.8.0 or 3.8.1. Affected systems include 25 units in the US and 26 units internationally across multiple countries. These systems are used in clinical laboratories to conduct automated blood chemistry testing.
The affected systems contain a software defect in the configurable Westgard Rules quality control feature. When a new control is defined, the Westgard rules do not flag or report failures when they should occur. This means quality control results that fail acceptance criteria may be incorrectly accepted and not flagged for operator review.
As a result, erroneous patient test results may be reported from the system without being caught by quality control checks. This could affect the accuracy of patient laboratory results and clinical decision-making. Any facility operating an affected VITROS XT 3400 Chemistry System should verify their system software version and serial number against the recall notice.
Affected facilities should contact Ortho-Clinical Diagnostics for instructions on obtaining and implementing the corrective software update to resolve the quality control reporting defect.
The recalled product
- Product
- VITROS XT 3400 Chemistry System, Catalog No. 6844458
- 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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