Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-3244-2018)

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:

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

Product Classification:

Class II

Date Initiated: July 13, 2018

Date Posted: October 3, 2018

Recall Number: Z-3244-2018

Event ID: 80585

Reason for Recall:

Analyzers were distributed with software which lacks a 510K

Status: Terminated

Product Quantity: 8 units

Code Information:

Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201

Distribution Pattern:

US Nationwide Distribution in states of - CA, OK, VA 7 WI

Voluntary or Mandated:

Voluntary: Firm initiated