Recall Z-2745-2018— Tosoh Bioscience Inc

Name: FDA recall Z-2745-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-06

Class II · Terminated

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-06-06, terminated 2021-02-09. It names one FDA 510(k) clearance: K100304. Product: G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.. Reason: HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE..

Recalling firm: Tosoh Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2018-06-06
Terminated: 2021-02-09
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K100304 — ST AIA PACK HBA1CTosoh Bioscience, Inc.·cleared 2010-08-27

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: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

Reason for recall

HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.

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