ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of hep...
FDA Recall #Z-1062-2018 — Class II — November 9, 2011
Product Description
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
Reason for Recall
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.
Recalling Firm
Hyphen BioMed — Neuville Sur Oise
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
94
Distribution
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Code Information
UDI: 03663537018770 Lot Number: F1700415
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated