Tosoh Bioscience Inc recalls AIA-900 Analyzer, Product code 022930, 022930R

Recall date

October 5, 2018

Source

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

Recall number

Z-0469-2019

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Distributed nationwide. Foreign distribution to Canada and Latin America.

Why it was recalled

Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.

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-900 Analyzer, Product code 022930, 022930R