medical Class II Updated 2018-11-21

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

Recalled Product

AIA-900 Analyzer, Product code 022930, 022930R

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units are affected
View official government recall

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