FDA Device recall Z-2745-2018
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560 by Tosoh Bioscience, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2745-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-06 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
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.
Identifiers
| code_info | All active analyzers with Version 5.23 Software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2745-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.