The customer reported conflicting results with the binaxnow covid-19 ag self test.As per the customer the first test generated a negative results.Additional testing with the binax now covid-19 ag self test generated two line the first line was very faint.The customer stated the patient was symptomatic with a fever.No additional patient information, including treatment and outcome, was provided.
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The customer was unwilling to provide the required intake information.The information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored via the current revision of j-0254-scr to identify and track any out-of-trend/unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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