FDA-Device2018-03-21Class II
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
Hyphen BioMed
Hazard
A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
Sold states
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Affected count
30
Manufactured in
155 rue d Eragny, Neuville Sur Oise, France
Products
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2018Don't want to check this manually?
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