Tosoh Bioscience Inc recalls Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated E…

Recall date

June 11, 2017

Source

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

Recall number

Z-0491-2018

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Worldwide Distribution - U.S. Nationwide - Latin America

Why it was recalled

This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.

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

What was recalled

Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.