U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
The manufacturer, HYPHEN BioMed, initiated a voluntary recall of the two lots via email. Distributors and end users are being notified and instructed to:
1) acknowledge receipt and understanding of notification, and 2) destroy affected products remaining in stock. For further questions, please call (513) 770-1993.
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
제품 설명
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.