Tosoh Bioscience Inc: Medical Device Recall in 2019 - (Recall #: Z-0673-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.

Product Classification:

Class II

Date Initiated: November 30, 2018

Date Posted: January 2, 2019

Recall Number: Z-0673-2019

Event ID: 81597

Reason for Recall:

Status: Terminated

Product Quantity: 24083 units

Code Information:

all lots

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated