Ortho-Clinical Diagnostics is recalling approximately 2,017 units of VITROS Chemistry Products OP Reagent Gen 15 (Model 680 1997). This reagent is a laboratory tool used to detect opiates in urine. The recall was initiated because certain production lots may produce lower than expected quality control results, which could prevent laboratories from performing the required testing protocol and lead to delays in providing patient results.
If a laboratory is unable to achieve valid quality control results, they will be unable to run the diagnostic test. This creates a risk of delayed patient results for opiate detection, though no specific injuries have been reported.
The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents. One sales unit contains 6 Microtip packs.
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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