Invalid result (s).We got a call from a customer that is having an issue with 2 flowflex covid 19 antigen test kit.The customer has just purchased the test kit, so this is an out of box issue.Customer called in because her test cassette has no c-line or t-line.Customer confirmed that he performed the test correctly, and had applied 4 drops of buffer solution to the s-well, and waited until 15-30 mins.No control line or test line appeared.Customer was able to send a picture of one of the cassette's, he had thrown 1 cassette away.Both kits have the same lot number and expiration date.I advised the customer that i need to forward this information to the appropriate department for review.Customer will wait for an email back from acon labs on this matter.
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Batch records for final product manufacturing and qc records for cov1120165 were reviewed and 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 cov1120165 met the qc criteria.The complaint issue was not found with the retained cassettes.The root cause is undertermined.Similar issues will be tracked and trended.
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