Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0485-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Tosoh AIA-900 immunoassay Analyzer

Product Classification:

Class II

Date Initiated: September 28, 2018

Date Posted: November 28, 2018

Recall Number: Z-0485-2019

Event ID: 81219

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.

Status: Terminated

Product Quantity: 3

Code Information:

10313605 10503612 10634103

Distribution Pattern:

Distributed to accounts in GA and NY.

Voluntary or Mandated:

Voluntary: Firm initiated