Z-0485-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- September 28, 2018
- Termination Date
- July 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Tosoh AIA-900 immunoassay Analyzer
Reason for Recall
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Distribution Pattern
Distributed to accounts in GA and NY.
Code Information
10313605 10503612 10634103