SEPPIM SAS recalls Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label show

Recalled November 13, 2013 · FDA recall Z-0178-2014 · SEPPIM SAS

Hazard

Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. · FDA Class II

Units

47 kits in US and 48 kits in Sweden

Sold at

Worldwide Distribution - US including the states of KY and UT and the country of Sweden.

Description

Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.

Product

Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

Manufacturer(s)

SEPPIM SAS

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →