Recall – Cl II G8 Automated HPLC Analyzer-723G8

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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