Wiener Laboratories recalls Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Recall date

November 10, 2017

Source

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

Recall number

Z-0924-2018

FDA classification

Class II

Brand / firm

Wiener Laboratories

Sold / distributed

Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.

Why it was recalled

Internal program testing shows that product may not reach the indicated expiration date.

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

What was recalled

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.