System, Analysis, Electrophoretic Hemoglobin

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

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

RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415,

Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.