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Health product recall

G8 Automated Glycohemoglobin System-Instrument

Starting date:: November 2, 2016
Posting date:: December 5, 2016
Type of communication:: Medical Device Recall
Subcategory:: Medical Device
Hazard classification:: Type II
Source of recall:: Health Canada
Issue:: Medical Devices
Audience:: General Public, Healthcare Professionals, Hospitals
Identification number:: RA-61272

Reason
Affected products

Reason

In the study "Effects of hemoglobin c, d, e and s traits on measurements of hemoglobin A1c (HbA1c) by twelve methods" published in Clinica Chimica ACTA, the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 variant analysis mode showed significant interference with HbA1c results with one or more variants at 9% HbA1c. Clinically significant interference was defined as >7% difference from HbAA at 6 or 9% HbA1c (+-0.42% or +-0.63% hba1c, respectively). The paper further explains that the Tosoh methods are ion-exchange HPLC where inspection of the chromatogram reveals the presence of the variant.

Affected products