Z-2745-2018 Class II Terminated
FDA device recall Z-2745-2018 was initiated by Tosoh Bioscience Inc on Jun 6, 2018 and is designated Class II. 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… The recall status is terminated (terminated Feb 9, 2021). Affected quantity: 665.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2018
- Initiation Date
- Jun 6, 2018
- Termination Date
- Feb 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 665
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.
Distribution Pattern
Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.
Code Information
All active analyzers with Version 5.23 Software
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2745-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026