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  • Andrew Drakeadrake@sfba.social
    Jul 9, 2026, 5:15 PM

    @joshua that's a good tip, thank you!

    While this probably would not work at the moment, back in 2021 IIRC I had a box of COVID tests where there wasn't enough extraction buffer for one of the tests in the kit. Lacking a convenient way to contact the manufacturer, and given that the total value was like $6, I spent 5 minutes filing a defective medical device report with the FDA, and didn't really expect anything else to happen.

    A couple weeks later I got a *phone call* from the test manufacturer apologizing for the defective test, and a promise that a new box of tests was in the mail (which showed up soon after).

    Amazing what a regulator who cares can do when you give them something to work with!

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  • Joshua Wisejoshua@emarhavil.com
    Jul 9, 2026, 5:18 PM
    @adrake I mean, on the one hand, blah blah it's just extraction buffer on a diagnostic test blah blah, and I am a little more sympathetic to that manufacturer than to an insurer.

    On the other hand, if their OQC program didn't detect that, are there other things that their OQC program didn't detect on other, more important, things they're making...?
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  • Andrew Drakeadrake@sfba.social
    Jul 9, 2026, 5:41 PM

    @joshua I was already somewhat annoyed with them because they were packaging the buffer in a separate little blister pack that you had to tear open and transfer to the sample tube, a finicky and sometimes lossy process. No surplus in the packet, even if you didn't spill any and squeezed it as flat as you could, it would still often end up a hair shy of the line (though I didn't complain about those).

    But I figured if they were already willing to skimp on the cheap visible component, they were probably willing to skimp on the expensive invisible antibodies, and if their QC let the easy thing through it's not promising for the more critical parts. (Not to mention any other devices the manufacturer might make!)

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