Ortho-Clinical VITROS 5600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may cause erroneous test results without user notification.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm (erroneous clinical results) are rated as Severe.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Chemistry System, Catalog Number 6802413, for use in in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes. The recall affects units with Software Version 3.2 and below, specifically Serial Numbers J56000024 through J56002309. The agency classifies this as a Class II recall.
The recall is due to a software anomaly that may allow the system to sample and process assays while fluids and reagent temperatures are outside the required range for optimal processing. When this intermittent issue occurs, the system continues to operate and process results without notifying the user, which may produce erroneous results.
The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous foreign countries such as Argentina, Australia, Brazil, Canada, and others. Domestic distribution involved 1,083 units, and foreign distribution involved 999 units. Users should contact Ortho-Clinical Diagnostics for instructions on how to address the software issue.
The recalled product
- Product
- VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a
- Manufacturer
- Ortho-Clinical Diagnostics
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 (2)
- Software Version 3.2 and below
- Serial Numbers J56000024 - J56002309
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ortho-Clinical Diagnostics 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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