FDAOctober 5, 2018device

AIA-900 Analyzer, Product code 022930, 022930R

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

tosoh biosciencetosoh

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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AIA-900 Analyzer, Product code 022930, 022930R — Recall Details · AllClear