Regulatory Open Forum

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  • 1.  IVD Test Kit - Missing Label

    This message was posted by a user wishing to remain anonymous
    Posted 28-Nov-2021 21:26
    This message was posted by a user wishing to remain anonymous

    If 1 or more IVD kits have been shipped to customers and may be missing labeling on the outer kit container that would have contained the kit Lot Number, expiration date, and Part number need to be recalled or have some other type of market action?  All other labeling is ok.  Kits may have been shipped in the US, Canada, and the EU.

    Thank you


  • 2.  RE: IVD Test Kit - Missing Label

    Posted 29-Nov-2021 05:54
    Unfortunately in many countries, missing or wrong labelling is considered mis-branding such as in the United States.  This is taken seriously even when aspects like lot numbers are transposed or expiration dates are incorrect.  Usually this would result in a Class III type of recall.  It may be possible to write a rationale or internal justification that the outer kit container label is missing, but would need to further understand all packaging levels of the product.  This also depends on the regulatory appetite the company would want to take.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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