Company: Tosoh Bioscience Inc
Date of Enforcement Report: 11/19/2018
Class II:

PRODUCT
Tosoh AIA-900 immunoassay Analyzer

Recall Number: Z-0485-2019

REASON
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.

RECALLING FIRM/MANUFACTURER
Tosoh Bioscience Inc, Grove City, OH on 9/28/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3

DISTRIBUTION
Distributed to accounts in GA and NY.