Explanation for device evaluated by mfr: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false negative test and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were two similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.A technical support representative reviewed customer data and performed data analysis.All data values were normal and met acceptable criteria.Root cause was undetermined.
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Customer reporting on behalf of his father.See case-(b)(4) for alternate false negative result.Individual received a false positive result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 18785d, reader sn (b)(4).On (b)(6) 2022, a nasal sample was collected at urgent care and returned a positive result on (b)(6) 2022.Customer states individual also had other rapid tests performed that came back positive (brand/manufacturer, frequency, and dates of testing not provided).Individual experienced symptoms (coughing) and potential exposure is unknown.Cartridges stored within the validated temperature range.
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