Multiple problems with ihealth covid-19 antigen rapid test kits--today's testing is an example.Both of 2 kits in one box in lot no.(10):222c020210 were faulty, unusable, due to an extremely faint positive control.This is about the 8th of these tests that i have found to be faulty due to incorrect control, not all in the same lot (expiries july to aug 22), not always both kits in same box of 2, and also in one box of 2 kits, only 1 kit was present (an extra copy of instructions had been inserted instead).This is not user error: i am a medical professional, and the fluid volume in the tube was correct (some kits have prefilled tubes, some must be filled by user--both have had incorrect controls), the drops used were correct and correctly administered on the kit and fluid diffused correctly to the end of the window (you can see it as a slight color change rolling across the test window).The kits have been within their extended expiry.Very poor quality control by manufacturer.No one was harmed, because testing was repeated, but to have to test 3 times in rapid succession to obtain a valid result is not acceptable, and of course the unusable kits were purchased (in this case, by federal government -- were part of mailed out kits -- or by local government, which distributes them in libraries).Fda safety report id# (b)(4).
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