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This event was reported to the fda under report # mw5099139.Patient reported as asymptomatic.Initial lumiradx sars-cov-2 ag test was performed on (b)(6) 2021 with strip lot 5000267.The initial test result was positive.Confirmatory testing was performed via polymerase chain reaction (pcr).The confirmatory test result was negative.Product handling practices observed and reported by the patient 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.A review of the product risk assessment confirmed the applicable risk categories remain appropriate for the reported event.A 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.Trending data for discordant results were reviewed and the occurrence rate for the reported strip lot demonstrated field performance within specification of product claims, until expiry, relative to the quantity of strips in the field.Investigation conclusion: strip lot was also subject to field correction in the form of an instrument software update, as documented under fda recall z-1312-2021, to correct a manufacturing issue (valve run out) that was attributed with an increased risk of false positives in a certain portion of strips within the lot.No further investigation is considered necessary at this time.The remaining strips from the lot that were not subject to the field correction, were used within the field until expiry and demonstrated field performance within the specification of product claims, relative to the quantity of strips in the field.
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