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Patient health status reported as asymptomatic.Initial lumiradx sars-cov-2 ag test was performed on (b)(6) 2024 with strip lot 6001214.The initial test result was positive.Confirmatory testing was performed via polymerase chain reaction (pcr).The confirmatory test result was negative.All customer reported product handling practices are consistent with product insert and swabs used have been validated for use with the lumiradx sars-cov-2 ag test.No patient harm, injury or adverse health consequences were communicated by the customer to lumiradx for the reported discordant result.Although, the customer identified there was delay of patient placement into appropriate facility to manage their care, based on the positive test result.Review of product risk assessment confirmed the applicable risk categories remain appropriate for the reported event.Review of manufacturing records identified that the reported strip lot met all defined qc criteria at the time it was released, and that in-house testing confirmed strip lot met expected performance criteria for use in the field.Review of trending data for discordant results was reviewed and the occurrence rate for the reported strip lot continues to demonstrate field performance within specification of product claims, relative to the quantity of strips in the field.Root cause determination: no definitive root cause has been determined for the reported discordant result based on the information currently available.Investigation conclusion and status of investigation: no further investigation is considered necessary at this time.This strip lot continues to demonstrate field performance within specification of product claims, relative to the quantity of strips in the field.Reports of discordant results for this lot will continue to be trended and reviewed, with action taken as appropriate in response to any adverse trends or events including a follow-up report.
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