Home / Recalls / Medical Devices
Tosoh Bioscience Inc recalls Tosoh AIA-900 immunoassay Analyzer
Recalled November 28, 2018 · FDA recall Z-0485-2019 · Tosoh Bioscience
Hazard
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. · FDA Class II
Units
3
Sold at
Distributed to accounts in GA and NY.
Description
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.
Product
Tosoh AIA-900 immunoassay Analyzer
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →