Tosoh Bioscience Inc recalls AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12…

Recall date

November 30, 2018

Source

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

Recall number

Z-0671-2019

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

US Nationwide

Why it was recalled

Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays

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

What was recalled

AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.