Everlywell covid-19 test kit label to attach to collection tube is not compatible with ink based pens.When writing a name and dob, the ink smears and or becomes illegible.The other test kit id label is pealing from the collection tube when received.The collection tube or test box do not have a expiry date, lot number, or serialization, presenting a significant risk for patients and contacts due to the potential for inaccurate results.A product compliant reporting mechanism was not readily found with a (b)(6) search or the website from everylwell.Accordingly, pharmacovigilance is significantly underrepresenting risk to patients.The above can be easily verified by obtaining an everlywell covid-19 test kit as well as trying to locate the product compliant hotline.It is recommended the fda conducts an audit of everlywell as these deficiencies likely represent more significant failures within the company requiring action to protect the public.Fda safety report id# (b)(4).
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