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ASR Rule and Mfg. Liability

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DNABIZ

Junior Member
What is the name of your state? California and Belgium

We are an IVD Mfg. we are entertaining producing our product for a CLIA certified organization, who will use our finished product as a component in a Clinical Assay.

Who would be responsible if a patient pursued legal action with respect to outcome of their test results?

Could the CLIA organization claim the mistake was caused at the component level and pass liability onto us as the Mfg?

Thanks
DNABIZ
 



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