Z-0469-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- October 5, 2018
- Termination Date
- November 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 393
Product Description
AIA-900 Analyzer, Product code 022930, 022930R
Reason for Recall
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.
Distribution Pattern
Distributed nationwide. Foreign distribution to Canada and Latin America.
Code Information
All units are affected