Tosoh Bioscience Inc recalls G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemo

Recalled October 3, 2018 · FDA recall Z-3244-2018 · Tosoh Bioscience

Hazard

Analyzers were distributed with software which lacks a 510K · FDA Class II

Units

8 units

Sold at

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

Description

Analyzers were distributed with software which lacks a 510K

Product

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.

Manufacturer(s)

Tosoh Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →