Response to device evaluated by manufacturer: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false positive test and a member of the technical support group was able to perform data analysis.Investigation summary: the complaint history was reviewed and there were no previous similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.A technical support representative reviewed customer data and noted that the cue reader was performing within specifications.To better address false positive test results, the cue reader firmware was upgraded to detect and cancel the test instead of releasing false positive results.The reader firmware in this case did not cancel the test.
|
Customer reports their child had a false positive result on (b)(6) 2022 using cue covid-19 test for home and over the counter (otc) use cartridge lot 21814l, cartridge serial number (b)(4), and cue reader serial number (b)(4).The customer received a negative result with a subsequent cue covid-19 test on (b)(6) 2022.The customer reports the child was not symptomatic.
|