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 both tests correctly , both test kits did not show a control line , or a test line.Both test kits have the same lot number and expiration date on the boxes, the customer only had the box when we talked with her.I asked the customer if she applied 4 drops of buffer solution to the s-well.
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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 cov1100068 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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