Tosoh Bioscience Inc recalls Tosoh AIA-900 immunoassay Analyzer

Recall date

September 28, 2018

Source

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

Recall number

Z-0485-2019

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Distributed to accounts in GA and NY.

Why it was recalled

A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.

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 AIA-900 immunoassay Analyzer