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Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent
Recalled March 21, 2018 · FDA recall Z-1063-2018 · 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. · FDA Class II
Units
30
Sold at
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Description
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.
Product
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.
Manufacturer(s)
Hyphen BioMed
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →