FDA-Device2018-05-16Class II
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.
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
281
Manufactured in
155 rue d Eragny, N/A, Neuville Sur Oise, N/A, France
Products
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1744-2018Don't want to check this manually?
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