Company: Tosoh Bioscience Inc.
Date of Enforcement Report 10/3/2018
Class lI:
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.
Recall Number: Z-3244-2018
REASON
Analyzers were distributed with software which lacks a 510K
RECALLING FIRM/MANUFACTURER
Tosoh Bioscience Inc. Grove City, OH on 7/13/2018 Voluntary: Firm Initiated
VOLUME OF PRODUCT IN COMMERCE
8
DISTRIBUTION
US Nationwide Distribution in states of – CA, OK, VA 7 WI
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