Tosoh Bioscience Inc recalls G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemo…

Recall date

June 6, 2018

Source

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

Recall number

Z-2745-2018

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.

Why it was recalled

HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.

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: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.