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 positive test and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were no similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.The investigation is still in process.Findings and the conclusion will be provided in a supplemental report after the investigation has been concluded.
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Customer reports receiving a potential false positive result on (b)(6) 2022 when testing with the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 26544b, reader sn (b)(4).Two repeat cue tests performed on the same day provided negative results.
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