Ortho-Clinical Diagnostics, Inc. is recalling approximately 1,718 units of the VITROS Chemistry Products Calibrator Kit 29. These kits were mistakenly labeled with an extended expiration date of July 24, 2025, when the correct expiration date for the affected lot is actually July 24, 2024. If the calibrator is used after its true expiration date and the system's software is not updated, it may cause the diagnostic system to produce biased or inaccurate test results for total iron-binding capacity (TIBC). While the calibrator is currently safe to use until its true expiration date in July 2024, action is required to ensure it is not used beyond that point.
Using the calibrator past its true expiration date can lead to biased laboratory results. This inaccuracy could potentially lead to incorrect medical diagnoses or inappropriate patient treatment for conditions related to iron levels.
Software/Data update and revised expiration date
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.
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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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