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Aniara Diagnostica LLC recalls ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Recalled August 28, 2019 · FDA recall Z-2346-2019 · Aniara Diagnostica
Hazard
Residual crystallization of the microplate and recurrent negative controls out of range. · FDA Class II
Units
51
Sold at
Distribution to US states of NC, NH, NY, and OH, and Sweden.
Description
Residual crystallization of the microplate and recurrent negative controls out of range.
Product
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Manufacturer(s)
Aniara Diagnostica LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →