VITROS 5600 Integrated System software anomaly reported
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.
What this means for you
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: This is an FDA Class II recall. No illnesses or injuries have been reported; the hazard is a software anomaly that could lead to erroneous or delayed test results without a documented history of patient harm. This qualifies as a moderate-severity recall under the rubric.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS 5600 Integrated System (Model/Catalog Numbers 6802413 and 6802915, with serial numbers ranging from 56000143 to 56005096) worldwide. A software anomaly allows test results to be reported using expired Micro Tip and Micro Slide diluent packs even when the system's Use Expired Reagents setting is not enabled, if a shelf expiration date is omitted during manual loading.
The issue was identified after a customer reported processing a CREA Urine test that generated a Reagent Expired (RE) code, despite the diluent pack not being expired and the use-expired-reagents setting being disabled. This anomaly can result in erroneous test results and/or delayed test results.
The recall affects 3,117 units: 813 in the United States and 2,304 internationally distributed to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom. Affected customers should contact Ortho-Clinical Diagnostics for additional information and guidance on remediation.
The recalled product
- Product
- Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
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 (5)
- VITROS 5600 Integrated System
- Product Code: 6802413
- UDI: 10758750002740
- VITROS 5600 Integrated System - Certified/Refurbished
- Product Code: 6802915
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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