Recall Z-3244-2018— Tosoh Bioscience Inc

Name: FDA recall Z-3244-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-13

Class II · Terminated

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-07-13, terminated 2020-07-08. It names one FDA 510(k) clearance: K131580. 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.. Reason: Analyzers were distributed with software which lacks a 510K.

Recalling firm: Tosoh Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Terminated: 2020-07-08
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8Tosoh Bioscience, Inc.·cleared 2014-01-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Analyzers were distributed with software which lacks a 510K

Data sourced from openFDA. This site is unofficial and independent of the FDA.