Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 2,413 units of the VITROS 5600 Integrated System, Version 3.3.1 and below. The recall covers both new and refurbished units distributed nationwide in the United States.
The recall is being issued because a software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. This system is used for in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
Affected units include Product Code 6802413 (Serial Numbers J56000024 through J56003358) and Product Code 6802915 (Refurbished, UDI 10758750007110) with specific serial numbers listed in the agency record. Users should contact Ortho-Clinical Diagnostics for further instructions on how to address the software issue.
The recalled product
- Product
- VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITR
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 2,413
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 (1)
- 1) Product Code 6802413 UDI 10758750002740
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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