FDA recall Z-0485-2019

Tosoh Bioscience Inc · Class II · device

Product

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

Distributed to accounts in GA and NY.

Key facts

Status
Terminated
Initiation date
2018-09-28
Report date
2018-11-28
Termination date
2020-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2019