Five (5) in vitro diagnostic covid-19 antigen self-tests authorized under eua (b)(4) for home use were administered as directed on (b)(6) 2022 - (b)(6) 2022.Of these 5 tests (manufacturer: accessbio, distributor: (b)(4), ref: rcpm-00279, lot: cp21k21, exp: mar 2022) 4 showed invalid results, and all 5 failed to perform as expected (lateral flow test failed to run full distance of test strip).Upon inspection, the 5th test was found to have a crack near the center of the test strip.No damage was visible to the packaging at time of testing.Photos of 3 of the tests following completion of the 10 minute testing window are attached.Fda safety report id# (b)(4).
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