Device product
AIA-900 Analyzer, Product code 022930, 022930R
Z-0469-2019
Product summary
- Event
- Event 81187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 393
- Official record key
device-enforcement:Z-0469-2019
Official wording
Reason: 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.
Code information: All units are affected
Distribution pattern: Distributed nationwide. Foreign distribution to Canada and Latin America.
Derived failure modes
-
Unknown
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.