Z-2745-2018Class II

G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674

Name: Z-2745-2018 G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674
Creator: Tosoh Bioscience Inc
Published: 2018-06-06
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-06-06 / Terminated / root cause: software

FDA source

Tosoh Bioscience Inc began a recall of G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended... on 2018-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2745-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-06
Posted: 2018-08-11
Terminated: 2021-02-09
Recalling firm: Tosoh Bioscience Inc
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued an Urgent Medical Device Recall letter to its affected customers on June 6, 2018. In the notice, Tosoh is currently investigating a resolution to this issue to eliminate interference from hemoglobin variants. In the interim, customers should carefully review the chromatography to determine whether or not a variant peak is detected and follow the recommendations included in the letter. Customers were asked to complete and return the attached Acknowledgement Form and the flag setting confirmation to Tosoh Bioscience, Inc., within 14-days of receiving this notification by FAX, email, or postal mail as indicated on the form. If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.
Quantity in commerce: 665
Distribution: Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.
Product codes and lots: All active analyzers with Version 5.23 Software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2745-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2745-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10

Product code LCP

K100304Class IISt Aia Pack Hba1cTosoh Bioscience, Inc. / cleared 2010-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)