Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent…

Recall date

November 9, 2011

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1063-2018

FDA classification

Class II

Brand / firm

Hyphen BioMed

Sold / distributed

Worldwide Distribution - US Distribution and to the countries of : Austria and France.

Why it was recalled

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.

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. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.