Tosoh Bioscience Inc: Medical Device Recall in 2019 - (Recall #: Z-0674-2019)

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 Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

Product Classification:

Class II

Date Initiated: November 30, 2018

Date Posted: January 2, 2019

Recall Number: Z-0674-2019

Event ID: 81597

Reason for Recall:

Status: Terminated

Product Quantity: 26745 units

Code Information:

all lots

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated