Ortho-Clinical Diagnostics is recalling approximately 6,123 VITROS 5600 and XT 7600 Integrated Systems, as well as VITROS 3600 Immunodiagnostic Systems. The recall is due to a software issue (version 3.8.0 or higher) that may fail to alert laboratory operators when Signal Reagent Packs have exceeded their expiration dates. These systems are used in clinical laboratories to perform chemistry and immunodiagnostic testing. The affected units were manufactured and distributed between June 2008 and the present. No injuries or incidents have been reported to date.
If the systems fail to identify and block the use of expired reagents, they may produce erroneous test results or fail to provide a result. This could lead to incorrect patient diagnoses or inappropriate medical treatment based on faulty lab data.
Quantity Distributed: 3,249 units (905 US, 2,344 Outside US). Catalogue number 6802415/6802915 denotes refurbished/certified systems which maintain their original serial numbers.
Quantity Distributed: 1,893 units (994 US, 899 Outside US). Certified systems (6272222) maintain original serial numbers.
Quantity Distributed: 981 units (99 US, 882 Outside US). Certified/Refurbished systems (6802914) maintain original serial numbers.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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