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

Recall date

July 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3244-2018

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

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

Why it was recalled

Analyzers were distributed with software which lacks a 510K

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.