No abnormal issue was found in the manufacturing process, technical testing and quality control inspection, and the manufacturing process.The test results of retention samples of cov1100063 met the qc criteria.The complaint issue was not reproduced with the retention samples.The root cause is undertermined.Similar issues will be tracked and trended.
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Invalid result (s).We got a call from a customer that is having an issue with a flowflex covid 19 antigen test kit.The customer has just purchased the test kit, so this is an out of box issue.When the customer performed the test correctly , the result did not show a control line , or a t-line (test line).I asked the customer if he applied 4 drops of buffer solution to the s-well.The customer confirmed that after the 15 minute mark, there was no control line or test line.The customer had thrown away the test cassette by the time we i called her back.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for an email response from acon labs regarding this matter.
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