Date of event provided in section b3 is an approximation, was not provided by consumer.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 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.H3 other text : single-use, device discarded.
|
The consumer reported two false negative results via social media with the binaxnow covid-19 antigen self-test performed on an unknown date.This mfr.Report addresses test one (1) of two (2).Additional testing was performed (at the clinic) on an unknown date with an unknown brand test (platform - unknown) which generated a positive result.The consumer stated that the patient was tested positive for pneumonia at the clinic.No additional information, including patient treatment and outcome, was provided.
|