Tosoh Bioscience Inc recalls ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker

Recall date

March 5, 2018

Source

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

Recall number

Z-2065-2018

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

Why it was recalled

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

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

What was recalled

ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker