VITROS 5600 Integrated System Software Anomaly Causes Erroneous Test Results
A software anomaly in the VITROS 5600 causes the system to incorrectly treat unexpired reagent packs as expired, potentially producing erroneous test results. The manufacturer is recalling affected units.
What this means for you
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 a Class II medical device recall involving a software defect that can result in erroneous test results. No illnesses, injuries, or deaths have been reported. The hazard is theoretical—wrong laboratory results could potentially lead to incorrect clinical decisions—and falls under risk-of-harm products where injury has not yet been reported.
Plain-English summary
The VITROS 5600 Integrated System is a laboratory analyzer manufactured by Ortho-Clinical Diagnostics that performs clinical laboratory tests. A software anomaly has been identified in this system.
The software flaw allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired, even when the "Use Expired Reagents" setting is not enabled and the diluent pack is not actually expired. This occurs when the shelf expiration date is omitted during manual loading of reagents into the system.
The issue was identified through a customer complaint where a CREA Urine test was processed with an RE (Reagent Expired) code despite the diluent pack not being expired and the use-expired-reagents setting being disabled. This software anomaly can result in erroneous test results and/or delayed test results.
Ortho-Clinical Diagnostics is recalling 3,117 units of the VITROS 5600 Integrated System (813 units in the US and 2,304 units distributed internationally 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 systems have serial numbers ranging from 56000143 to 56005096.
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.
- Hazard
- software-defect
- erroneous-test-results
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.
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