Ortho-Clinical Diagnostics, Inc. has recalled approximately 1,000 units of VITROS Chemistry Products FS Diluent Pack 3, specifically Lot 01-1645. This laboratory diluent is used during blood testing to prepare patient samples for C-Reactive Protein (CRP) analysis. The product was recalled because it may cause test results to be negatively biased, meaning the results could appear lower than they actually are, potentially leading to incorrect medical interpretations. Consumers who have had CRP testing performed with this specific diluent lot may need to have their results reviewed by a physician.
The affected diluent can cause inaccurately low C-Reactive Protein (CRP) test results. This bias could lead healthcare providers to underestimate the level of inflammation or infection in a patient, potentially delaying necessary medical treatment or resulting in a misdiagnosis.
Technical review and manufacturer consultation
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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