FDA Device

HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France

Hazard

The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.

What You Should Do

Remedy

Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.

Products

HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
Brand
Sebia, Inc.
UPC
Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.

Units Affected

71 kits