FDA-Device2018-10-03Class II
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.
Tosoh Bioscience Inc
Hazard
Analyzers were distributed with software which lacks a 510K
Sold states
US Nationwide Distribution in states of - CA, OK, VA 7 WI
Affected count
8 units
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3244-2018Don't want to check this manually?
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