FDA (Devices) recall action 83487
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Residual crystallization of the microplate and recurrent negative controls out of range.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.
Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.