Aniara Diagnostica LLC recalls ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Recall date
- July 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2347-2019
- FDA classification
- Class II
- Brand / firm
- Aniara Diagnostica LLC
- Sold / distributed
- Distribution to US states of NC, NH, NY, and OH, and Sweden.
Why it was recalled
Residual crystallization of the microplate and recurrent negative controls out of range.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
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