VITROS 4600 Chemistry System Software Defect Affects Quality Control Reporting
A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.
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 with no reported illnesses, injuries, or deaths. The defect creates risk of erroneous patient results through quality control reporting failures. Under the rubric, risk-of-harm products without reported injury are rated High (3).
Plain-English summary
A software defect in the VITROS 4600 Chemistry System affects units running software versions 3.8.0 or 3.8.1. The defect prevents the system's Configurable Westgard Rules—a quality control mechanism—from being flagged or reported when defined criteria are met.
When quality control rules are not properly reported, the system may accept and report quality control results that do not meet acceptance standards, potentially resulting in erroneous patient results being released to healthcare providers.
The recall affects 15 units in the United States and 43 units outside the United States, including Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, the Netherlands, and the United Kingdom.
The recalled product
- Product
- VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (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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