The customer reported false positive result with the binax now covid-19 antigen self test performed on (b)(6) 2021.The customer stated that the control side was a pink line and no pink line on sample side, and the test results read an (1) hour later then the customer see's a faint pink line on the sample side.As per the customer two (2) test was performed on the binaxnow covid-19 ag and generated negative results.Pcr confirmation testing was performed and generated negative result.The customer stated patient was symptomatic with a cough and had taken ibuprofen.No additional patient information, including treatment and outcome, was provided.
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B5: correction report.It was initially reported that the consumer read the results from the binaxnow covid-19 ag antigen self test which indicated a negative result by showing a pink line on the control and no line on the sample.Consumer then reported after reading the results approximately one hour later, there was a faint pink line on the sample.Upon further review, this event should not have been reported as this is user error with no medical intervention or harm as a result.The product insert for binaxnow covid-19 ag antigen self test indicates that the results are to be read between the fifteen and thirty minute mark and that any results read outside of that timeframe should not be considered valid.
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