Diasorin Inc. recalls DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit…

Recall date

March 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1464-2015

FDA classification

Class II

Brand / firm

Diasorin Inc.

Sold / distributed

Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.

Why it was recalled

Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.