FDA-Device2018-05-16Class II
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
Hyphen BioMed
Hazard
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Sold states
OH, MD, NC, NY, NH, Canada, Sweden
Affected count
60
Manufactured in
155 rue d Eragny, N/A, Neuville Sur Oise, N/A, France
Products
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2018Don't want to check this manually?
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