ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST; ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP
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Lot Number COV2020015 |
Device Problem
No Device Output (1435)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 cov2020015 met the qc criteria.The complaint issue was not reproduced with the retention samples.The root cause is undetermined.Similar issues will be tracked and trended.
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Event Description
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Invalid result (s).User stated that, "after following all directions, even the control never changed colors." they performed the test procedure according to the directions, but a result did not develop.
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Search Alerts/Recalls
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