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Tosoh Bioscience Inc recalls AIA-900 Analyzer, Product code 022930, 022930R
Recalled November 21, 2018 · FDA recall Z-0469-2019 · Tosoh Bioscience
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. · FDA Class II
Units
393
Sold at
Distributed nationwide. Foreign distribution to Canada and Latin America.
Description
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.
Product
AIA-900 Analyzer, Product code 022930, 022930R
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →